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Rigorous Exercise May Delay Hip Replacement

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SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

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SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

SAN DIEGO – A 3-month exercise program appears to have significantly delayed, and perhaps even prevented, hip replacements in a Norwegian randomized, controlled trial.

Within the first 6 years after participating in the exercise program, 40% (22) of patients had gotten a hip replacement; in the control group, 57% (31) had gotten an artificial hip during the follow-up period.

The 109 patients who started the trial had mild to moderate hip pain and were not yet eligible for surgery. They went through three 90-minute education sessions where they were told to stay active, even if it hurts a bit.

The message was "don’t be afraid of your pain. It won’t damage your cartilage" and might improve symptoms, said researcher Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

Immediately after the education part of the trial, 55 patients were randomized to a 3-month, supervised strength and flexibility exercise program.

"We pushed them quite hard," Dr. Fernandes said at the World Congress on Osteoarthritis. They "had to exercise at 70-80% of [their] maximum" for over 1 hour. Patients attended, on average, about twice a week; 80% completed 20 sessions.

In spring 2011 – 3.5 to 6 years after the exercise program – Dr. Fernandes and her associates telephoned patients in both arms of the trial to learn if they had a subsequent hip replacement.

The results were "kind of surprising to us," said senior author and physiotherapist May Arna Risberg, Ph.D., a professor in the sport medicine department at the Norwegian School of Sport Sciences in Oslo.

"If you exercise early, maybe you can prevent [hip] surgery long-term."

Among patients who had gotten an artificial hip, the median time to surgery in the exercise group was 5.4 years; it was 3.5 years in the control group. Exercise patients also had significantly less pain and better function, not only in the spring of 2011 but also at earlier follow-up points.

The two groups were evenly balanced, with no significant baseline differences in age, gender, joint space, Harris Hip Score, and self-reported pain and function.

"There is something going on here, although it is hard for me to understand it," Dr. Risberg said. "I think it has something to do with the 12-week program. We also saw that the progression of radiographic osteoarthritis was significantly worse in the patients that did not get supervised exercise. The mechanism for how this works we don’t know."

Perhaps patients in the exercise group learned, instead of just being told, that a reasonable amount of hip pain is tolerable. Maybe they were less afraid to be active and so stayed active, while their peers in the control arm of the study did not, Dr. Fernandes said.

"If you exercise early" in the course of the disease, "maybe you can prevent surgery long-term," she said. "But that is just a theory. We can’t really say anything about cause and effect here."

Patients worked on 26 exercises, including squats, crunches, cycling, and stepping. If they learned how to balance on one foot, patients were put on a balance pad to make it harder. If they got to the point where they could do eight leg curls, "we increased the load," Dr. Fernandes said. If pain got to be too much, they backed off the exercise until it diminished (Phys. Ther. 2010;90:592-601).

The team collected data on cardiovascular and other physiologic parameters in the two groups but has not analyzed them yet. They also surveyed how active patients were at various follow-up points, but lost confidence in their assessment scale – the Physical Activity Scale for the Elderly (PASE) – after one of the researchers determined it was not valid for their setting.

To date, there have been few randomized controlled trials to see if exercise helps hip osteoarthritis, though exercise is known to help knee osteoarthritis, Dr. Risberg said.

Patients in the study were 40-80 years old and had hip pain for more than 3 months, radiographically confirmed hip osteoarthritis, Harris Hip Scores of 60-95, and no previous joint replacements.

The next best step would be a larger randomized trial, Dr. Fernandes said, but in the meantime the team is analyzing patients’ biomechanics to see if they correlate with the outcomes.

"We have to look into this further," Dr. Fernandes said.

The congress was sponsored by the Osteoarthritis Research Society International.

The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

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FROM THE WORLD CONGRESS ON OSTEOARTHRITIS

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Major Finding: After going through a rigorous 3-month exercise program, 40% (22) of patients with hip osteoarthritis got a hip replacement within 3.5 to 6 years; 57% (31) of their control-group peers who did not go through the exercise program got an artificial hip during the same period.

Data Source: Randomized controlled trial involving 109 patients.

Disclosures: The study was funded by the Norwegian Foundation for Health and Rehabilitation, the Norwegian Rheumatism Association, and the South-Eastern Norway Regional Health Authority. The researchers said they have no disclosures.

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Address Nonoperative Limb After Knee Surgery

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SAN DIEGO – It’s important to pay attention to both knees – the knee that was operated on as well as the knee that wasn’t operated on – after a unilateral, medial, opening-wedge high tibial osteotomy.

Joint load increases in the nonoperative knee following the procedure, which is used to correct varus malalignment, according to researchers at the University of Western Ontario, London.

The findings apply to a subset of opening wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.

In 38 such patients, 2 years after surgery "we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb," as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.

"The major point is to pay attention to what’s happening to the opposite knee, to make sure you are not ignoring it and focusing your entire treatment plan on just looking at the operative knee," he said.

An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease

During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee. "Our surgeons are particularly careful to not over-correct," Mr. Boulougouris said.

Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m2. Varus malalignment in the operative limb was about 11 degrees and Kellgren-Lawrence grades ranged from 1 to 3. Varus malalignment was about 8 degrees in the nonoperative limb, with Kellgren-Lawrence grades ranging from 0 to 1.

Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.

Knee adduction moment had also significantly decreased on the operative side (mean change, –1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, –1.43 degrees). The findings were statistically significant.

The reasons could include the operation itself, disease progression in the nonoperative knee, or the fact that patients had gained an average of about 4.5 pounds at the 2-year follow-up.

Mr. Boulougouris said that he doubts the weight gain had much to do with it. He and his colleagues hope to tease out the contributing factors in a regression analysis.

The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris reported that he had no relevant financial conflicts of interest to disclose.

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SAN DIEGO – It’s important to pay attention to both knees – the knee that was operated on as well as the knee that wasn’t operated on – after a unilateral, medial, opening-wedge high tibial osteotomy.

Joint load increases in the nonoperative knee following the procedure, which is used to correct varus malalignment, according to researchers at the University of Western Ontario, London.

The findings apply to a subset of opening wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.

In 38 such patients, 2 years after surgery "we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb," as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.

"The major point is to pay attention to what’s happening to the opposite knee, to make sure you are not ignoring it and focusing your entire treatment plan on just looking at the operative knee," he said.

An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease

During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee. "Our surgeons are particularly careful to not over-correct," Mr. Boulougouris said.

Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m2. Varus malalignment in the operative limb was about 11 degrees and Kellgren-Lawrence grades ranged from 1 to 3. Varus malalignment was about 8 degrees in the nonoperative limb, with Kellgren-Lawrence grades ranging from 0 to 1.

Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.

Knee adduction moment had also significantly decreased on the operative side (mean change, –1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, –1.43 degrees). The findings were statistically significant.

The reasons could include the operation itself, disease progression in the nonoperative knee, or the fact that patients had gained an average of about 4.5 pounds at the 2-year follow-up.

Mr. Boulougouris said that he doubts the weight gain had much to do with it. He and his colleagues hope to tease out the contributing factors in a regression analysis.

The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris reported that he had no relevant financial conflicts of interest to disclose.

SAN DIEGO – It’s important to pay attention to both knees – the knee that was operated on as well as the knee that wasn’t operated on – after a unilateral, medial, opening-wedge high tibial osteotomy.

Joint load increases in the nonoperative knee following the procedure, which is used to correct varus malalignment, according to researchers at the University of Western Ontario, London.

The findings apply to a subset of opening wedge high tibial osteotomy (HTO) patients, those who present initially with significant bilateral varus, but in whom symptoms were severe enough to require surgery in only one knee.

In 38 such patients, 2 years after surgery "we noted a 0.25% [of body weight times height] increase in peak knee adduction moment in the non-operative limb," as well as a slight increase in vertical ground reaction force, said lead author and physiotherapist Angelo Boulougouris, a biomechanics doctoral candidate at the school. The external knee adduction moment measured during gait is an indicator of tibiofemoral joint osteoarthritis progression.

"The major point is to pay attention to what’s happening to the opposite knee, to make sure you are not ignoring it and focusing your entire treatment plan on just looking at the operative knee," he said.

An unloader brace, for instance, might be appropriate for the nonoperative knee, among other possible interventions, he said. An unloader brace is designed to lessen the stress on a knee with medial compartment knee osteoarthritis. This use of the unloader brace would be to prevent development of knee OA rather than to ease the discomfort associated with established disease

During HTO, a wedge of the cancellous bone allograft is placed in the proximal end of the tibia, correcting both varus deformity and weight distribution through the knee. "Our surgeons are particularly careful to not over-correct," Mr. Boulougouris said.

Of the 38 patients, 32 were men, the average age was about 50 and average body mass index (BMI) about 27 kg/m2. Varus malalignment in the operative limb was about 11 degrees and Kellgren-Lawrence grades ranged from 1 to 3. Varus malalignment was about 8 degrees in the nonoperative limb, with Kellgren-Lawrence grades ranging from 0 to 1.

Patients did well overall, reporting decreased pain and improved quality of life at 2 years. Varus malalignment was corrected in the operative limb, and unchanged in the nonoperative limb.

Knee adduction moment had also significantly decreased on the operative side (mean change, –1.99 % of body weight times height), but increased slightly on the nonoperative side. Gait changes also increased load on the nonoperative knee, including increased gait speed (mean change, 0.08 m/sec) and decreased trunk lean to the stance-phase limb (mean change, –1.43 degrees). The findings were statistically significant.

The reasons could include the operation itself, disease progression in the nonoperative knee, or the fact that patients had gained an average of about 4.5 pounds at the 2-year follow-up.

Mr. Boulougouris said that he doubts the weight gain had much to do with it. He and his colleagues hope to tease out the contributing factors in a regression analysis.

The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris reported that he had no relevant financial conflicts of interest to disclose.

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FROM THE WORLD CONGRESS ON OSTEOARTHRITIS

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Major Finding: At 2 years after a unilateral, opening-wedge high tibial osteotomy, 38 patients experienced a mean 0.25% body weight times height increase in peak knee adduction moment in the nonoperative limb.

Data Source: Comparison of baseline values to 2-year postop values.

Disclosures: The study was funded by the Canadian Institute of Health Research. Mr. Boulougouris said he had no disclosures.

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Hand OA Questionnaires Miss Problems Important to Patients

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Hand OA Questionnaires Miss Problems Important to Patients

SAN DIEGO – Hand osteoarthritis causes patients a wide range of daily problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.

In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more said buttoning and unbuttoning clothes were hard, as was carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.

Those items are among the nine tasks asked about on the widely used hand OA questionnaire, the Australian/Canadian (AUSCAN) Hand Osteoarthritis Index, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

However, more than half of the Norwegian sample had a hard time opening bottles, too. About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

Patients also did not mention problems putting on jewelry; opening doors and turning on faucets weren’t problems either, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. All three items are on the AUSCAN, Dr. Fernandes said.

"The outcome measures we have today," which also include Dreiser’s Functional Index, "are all expert opinion–based questionnaires. They haven’t really asked the patients themselves" about their daily struggles, she said.

She and her colleagues are using their findings to develop what they hope will be a more comprehensive questionnaire, but they declined to give details pending publication.

In the meantime, physicians might learn more about the challenges their OA patients face by going beyond current questionnaires; the study suggests additional things about which to ask. For many chores, there are tools to help, such as lid handles to open jars. Grip-strength exercises and range of motion exercises, especially for the thumb, may also help, Dr. Fernandes said.

In general, patients said they were still able to perform the tasks they listed, just not as well as before. Pain or fear of it might have had something to do with the problems, she said.

The study included 201 women and 10 men recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim. They were 63 years old on average, with a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.

The Norwegian Occupational Therapy Association and the Oslo Rheumatism Association paid for the study. Dr. Fernandes said she has no disclosures.

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SAN DIEGO – Hand osteoarthritis causes patients a wide range of daily problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.

In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more said buttoning and unbuttoning clothes were hard, as was carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.

Those items are among the nine tasks asked about on the widely used hand OA questionnaire, the Australian/Canadian (AUSCAN) Hand Osteoarthritis Index, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

However, more than half of the Norwegian sample had a hard time opening bottles, too. About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

Patients also did not mention problems putting on jewelry; opening doors and turning on faucets weren’t problems either, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. All three items are on the AUSCAN, Dr. Fernandes said.

"The outcome measures we have today," which also include Dreiser’s Functional Index, "are all expert opinion–based questionnaires. They haven’t really asked the patients themselves" about their daily struggles, she said.

She and her colleagues are using their findings to develop what they hope will be a more comprehensive questionnaire, but they declined to give details pending publication.

In the meantime, physicians might learn more about the challenges their OA patients face by going beyond current questionnaires; the study suggests additional things about which to ask. For many chores, there are tools to help, such as lid handles to open jars. Grip-strength exercises and range of motion exercises, especially for the thumb, may also help, Dr. Fernandes said.

In general, patients said they were still able to perform the tasks they listed, just not as well as before. Pain or fear of it might have had something to do with the problems, she said.

The study included 201 women and 10 men recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim. They were 63 years old on average, with a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.

The Norwegian Occupational Therapy Association and the Oslo Rheumatism Association paid for the study. Dr. Fernandes said she has no disclosures.

SAN DIEGO – Hand osteoarthritis causes patients a wide range of daily problems, but popular functional assessment questionnaires may miss many of them, Norwegian researchers have found.

In response to a survey question, 211 Norwegians with hand osteoarthritis (OA) listed 311 tasks their OA made more challenging. Wringing out cloths and opening jars was a struggle for more than half. A third or more said buttoning and unbuttoning clothes were hard, as was carrying suitcases and other heavy objects. More than 20% reported having a hard time peeling raw vegetables.

Those items are among the nine tasks asked about on the widely used hand OA questionnaire, the Australian/Canadian (AUSCAN) Hand Osteoarthritis Index, said lead investigator Linda Fernandes, Ph.D., a physiotherapist at Diakonhjemmet Hospital in Oslo.

However, more than half of the Norwegian sample had a hard time opening bottles, too. About a third said writing by hand and slicing bread were tough. About 20% or more said knitting, putting on socks, vacuuming, carrying shopping bags, zipping pants, and wiping down floors, among other chores, were problems, and some patients listed those items as priorities. None are on the AUSCAN, she said at the World Congress on Osteoarthritis, sponsored by the Osteoarthritis Research Society International.

Patients also did not mention problems putting on jewelry; opening doors and turning on faucets weren’t problems either, likely because doors in Scandinavia have turning handles, not doorknobs, and most sinks have a single lever to control hot and cold water. All three items are on the AUSCAN, Dr. Fernandes said.

"The outcome measures we have today," which also include Dreiser’s Functional Index, "are all expert opinion–based questionnaires. They haven’t really asked the patients themselves" about their daily struggles, she said.

She and her colleagues are using their findings to develop what they hope will be a more comprehensive questionnaire, but they declined to give details pending publication.

In the meantime, physicians might learn more about the challenges their OA patients face by going beyond current questionnaires; the study suggests additional things about which to ask. For many chores, there are tools to help, such as lid handles to open jars. Grip-strength exercises and range of motion exercises, especially for the thumb, may also help, Dr. Fernandes said.

In general, patients said they were still able to perform the tasks they listed, just not as well as before. Pain or fear of it might have had something to do with the problems, she said.

The study included 201 women and 10 men recruited consecutively as they presented to rheumatology clinics in Oslo and Trondheim. They were 63 years old on average, with a mean disease duration of 12.5 years and 8.6 affected joints; 64% had a comorbidity, 49% were employed.

The Norwegian Occupational Therapy Association and the Oslo Rheumatism Association paid for the study. Dr. Fernandes said she has no disclosures.

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Major Finding: When asked, 211 Norwegians with hand osteoarthritis listed 311 tasks their OA made difficult.

Data Source: Survey conducted using the Australian/Canadian Hand Osteoarthritis Index.

Disclosures: The study was paid for by the Norwegian Occupational Therapy Association and the Oslo Rheumatism Association. Dr. Fernandes said she has no disclosures.

Oral Calcitonin Found Beneficial in Knee Osteoarthritis

A Tough Sell to Regulators
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SAN DIEGO – Oral salmon calcitonin significantly reduced pain and stiffness, improved physical function, and slowed cartilage loss, especially in the medial tibial compartment in a 2-year, placebo-controlled, phase III clinical trial involving 1,169 patients with painful knee osteoarthritis.

But the trial did not meet one of its primary end points, improvement in joint space width.

Even so, "this pivotal phase III clinical trial suggests that oral salmon calcitonin," dosed at 0.8 mg twice daily for 24 months, "is safe, and has sustained symptom-modifying" benefits in osteoarthritis and "some structure-modifying effects," said Dr. Morten Karsdal, CEO of Nordic Bioscience in Herlev, Denmark, which sponsored the trial and is developing the drug in collaboration with Novartis Pharma.

Oral calcitonin (oCT) holds the promise of offering the benefits of calcitonin – widely used for osteoporosis, among other problems – without the immunogenicity of currently available nasal and injectable formulations.

At month 24, 17% of the 585 oCT subjects had circulating antibodies against the drug; historically, 40%-70% of users develop antibodies against nasal and injectable formulations, Dr. Karsdal said.

The mean age of trial subjects was 64 years, and mean body mass index about 29 kg/m2; 68% were women. Most patients had Kellgren-Lawrence grade II disease, the rest were grade III. Rescue medication was allowed in both the placebo and treatment arms.

By month 24, oCT subjects demonstrated about a 5% loss in cartilage volume on MRI in both the signal and non-signal knee; placebo subjects demonstrated slightly more than a 7% loss in both knees. The differences were statistically significant.

"We prevent a decrease; we do not gain cartilage," Dr. Karsdal said.

Also at month 24, oCT bested placebo in WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index pain scores (–115.7 vs. –94.9 mm; P = .002), function scores (–338.7 vs. –283.0 mm; P = .013), and stiffness scores (–44.1 vs. –32.6 mm; P less than .001).

It took about 6 months of treatment before oCT began to clearly separate from placebo on the WOMAC pain score.

Oral calcitonin also beat placebo on 24-hour visual analog scale (VAS) pain scores (P = .018), patient global assessment (P = .008), and physician global assessment (P = .014).

The most common adverse events in the oCT group, vs. placebo, were hot flashes (18% vs. 4%), nausea (14% vs. 3%), dyspepsia (10% vs. 5%), and diarrhea (10% vs. 4%).

Almost 20% of oCT subjects dropped out of the trial because of those and other side effects; the drug-related discontinuation rate in the placebo arm was 6%.

The side effects "are associated with the mode of action of salmon calcitonin, and mostly happened early," Dr. Karsdal said.

The trial was sponsored by Nordic Bioscience, which is developing the drug in collaboration with Novartis Pharma. Dr. Karsdal is the CEO of Nordic Bioscience.

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"It’s potentially a really important piece of work. Right now, we don’t have any disease-modifying agents" for osteoarthritis, according to Dr. David Hunter.

"People took oral calcitonin for 2 years. That’s something that couldn’t be done with a nasal product. A lot of people develop allergies to the nasal product after a short period of time," he said.

Overall, "they hit the end points for pain and function. What the clinical relevance of those effects are, it’s difficult to know," said Dr. Hunter, who also expects that because the drug didn’t improve joint space, regulatory approval is going to be a hard sell.

Joint space improvement "is a relatively unresponsive end point," but one that "regulators currently want," he said.

Dr. Hunter is a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. He reported having no conflicts of interest.

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"It’s potentially a really important piece of work. Right now, we don’t have any disease-modifying agents" for osteoarthritis, according to Dr. David Hunter.

"People took oral calcitonin for 2 years. That’s something that couldn’t be done with a nasal product. A lot of people develop allergies to the nasal product after a short period of time," he said.

Overall, "they hit the end points for pain and function. What the clinical relevance of those effects are, it’s difficult to know," said Dr. Hunter, who also expects that because the drug didn’t improve joint space, regulatory approval is going to be a hard sell.

Joint space improvement "is a relatively unresponsive end point," but one that "regulators currently want," he said.

Dr. Hunter is a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. He reported having no conflicts of interest.

Body

"It’s potentially a really important piece of work. Right now, we don’t have any disease-modifying agents" for osteoarthritis, according to Dr. David Hunter.

"People took oral calcitonin for 2 years. That’s something that couldn’t be done with a nasal product. A lot of people develop allergies to the nasal product after a short period of time," he said.

Overall, "they hit the end points for pain and function. What the clinical relevance of those effects are, it’s difficult to know," said Dr. Hunter, who also expects that because the drug didn’t improve joint space, regulatory approval is going to be a hard sell.

Joint space improvement "is a relatively unresponsive end point," but one that "regulators currently want," he said.

Dr. Hunter is a rheumatologist, epidemiologist, and professor of medicine at the University of Sydney. He reported having no conflicts of interest.

Title
A Tough Sell to Regulators
A Tough Sell to Regulators

SAN DIEGO – Oral salmon calcitonin significantly reduced pain and stiffness, improved physical function, and slowed cartilage loss, especially in the medial tibial compartment in a 2-year, placebo-controlled, phase III clinical trial involving 1,169 patients with painful knee osteoarthritis.

But the trial did not meet one of its primary end points, improvement in joint space width.

Even so, "this pivotal phase III clinical trial suggests that oral salmon calcitonin," dosed at 0.8 mg twice daily for 24 months, "is safe, and has sustained symptom-modifying" benefits in osteoarthritis and "some structure-modifying effects," said Dr. Morten Karsdal, CEO of Nordic Bioscience in Herlev, Denmark, which sponsored the trial and is developing the drug in collaboration with Novartis Pharma.

Oral calcitonin (oCT) holds the promise of offering the benefits of calcitonin – widely used for osteoporosis, among other problems – without the immunogenicity of currently available nasal and injectable formulations.

At month 24, 17% of the 585 oCT subjects had circulating antibodies against the drug; historically, 40%-70% of users develop antibodies against nasal and injectable formulations, Dr. Karsdal said.

The mean age of trial subjects was 64 years, and mean body mass index about 29 kg/m2; 68% were women. Most patients had Kellgren-Lawrence grade II disease, the rest were grade III. Rescue medication was allowed in both the placebo and treatment arms.

By month 24, oCT subjects demonstrated about a 5% loss in cartilage volume on MRI in both the signal and non-signal knee; placebo subjects demonstrated slightly more than a 7% loss in both knees. The differences were statistically significant.

"We prevent a decrease; we do not gain cartilage," Dr. Karsdal said.

Also at month 24, oCT bested placebo in WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index pain scores (–115.7 vs. –94.9 mm; P = .002), function scores (–338.7 vs. –283.0 mm; P = .013), and stiffness scores (–44.1 vs. –32.6 mm; P less than .001).

It took about 6 months of treatment before oCT began to clearly separate from placebo on the WOMAC pain score.

Oral calcitonin also beat placebo on 24-hour visual analog scale (VAS) pain scores (P = .018), patient global assessment (P = .008), and physician global assessment (P = .014).

The most common adverse events in the oCT group, vs. placebo, were hot flashes (18% vs. 4%), nausea (14% vs. 3%), dyspepsia (10% vs. 5%), and diarrhea (10% vs. 4%).

Almost 20% of oCT subjects dropped out of the trial because of those and other side effects; the drug-related discontinuation rate in the placebo arm was 6%.

The side effects "are associated with the mode of action of salmon calcitonin, and mostly happened early," Dr. Karsdal said.

The trial was sponsored by Nordic Bioscience, which is developing the drug in collaboration with Novartis Pharma. Dr. Karsdal is the CEO of Nordic Bioscience.

SAN DIEGO – Oral salmon calcitonin significantly reduced pain and stiffness, improved physical function, and slowed cartilage loss, especially in the medial tibial compartment in a 2-year, placebo-controlled, phase III clinical trial involving 1,169 patients with painful knee osteoarthritis.

But the trial did not meet one of its primary end points, improvement in joint space width.

Even so, "this pivotal phase III clinical trial suggests that oral salmon calcitonin," dosed at 0.8 mg twice daily for 24 months, "is safe, and has sustained symptom-modifying" benefits in osteoarthritis and "some structure-modifying effects," said Dr. Morten Karsdal, CEO of Nordic Bioscience in Herlev, Denmark, which sponsored the trial and is developing the drug in collaboration with Novartis Pharma.

Oral calcitonin (oCT) holds the promise of offering the benefits of calcitonin – widely used for osteoporosis, among other problems – without the immunogenicity of currently available nasal and injectable formulations.

At month 24, 17% of the 585 oCT subjects had circulating antibodies against the drug; historically, 40%-70% of users develop antibodies against nasal and injectable formulations, Dr. Karsdal said.

The mean age of trial subjects was 64 years, and mean body mass index about 29 kg/m2; 68% were women. Most patients had Kellgren-Lawrence grade II disease, the rest were grade III. Rescue medication was allowed in both the placebo and treatment arms.

By month 24, oCT subjects demonstrated about a 5% loss in cartilage volume on MRI in both the signal and non-signal knee; placebo subjects demonstrated slightly more than a 7% loss in both knees. The differences were statistically significant.

"We prevent a decrease; we do not gain cartilage," Dr. Karsdal said.

Also at month 24, oCT bested placebo in WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index pain scores (–115.7 vs. –94.9 mm; P = .002), function scores (–338.7 vs. –283.0 mm; P = .013), and stiffness scores (–44.1 vs. –32.6 mm; P less than .001).

It took about 6 months of treatment before oCT began to clearly separate from placebo on the WOMAC pain score.

Oral calcitonin also beat placebo on 24-hour visual analog scale (VAS) pain scores (P = .018), patient global assessment (P = .008), and physician global assessment (P = .014).

The most common adverse events in the oCT group, vs. placebo, were hot flashes (18% vs. 4%), nausea (14% vs. 3%), dyspepsia (10% vs. 5%), and diarrhea (10% vs. 4%).

Almost 20% of oCT subjects dropped out of the trial because of those and other side effects; the drug-related discontinuation rate in the placebo arm was 6%.

The side effects "are associated with the mode of action of salmon calcitonin, and mostly happened early," Dr. Karsdal said.

The trial was sponsored by Nordic Bioscience, which is developing the drug in collaboration with Novartis Pharma. Dr. Karsdal is the CEO of Nordic Bioscience.

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Major Finding: After 24 months of treatment in patients with painful knee OA, a novel oral salmon calcitonin formulation beat placebo on WOMAC pain scores (–115.7 vs. –94.9 mm; P = .002), function scores (–-338.7 vs. –283.0 mm; P = .013), and stiffness scores (–44.1 vs. –32.6 mm; P less than .001).

Data Source: A multicenter, double-blind, randomized, placebo-controlled phase III clinical trial involving 1,169 subjects.

Disclosures: The trial was sponsored by Nordic Bioscience, which is developing the drug in collaboration with Novartis Pharma. Dr. Morten Karsdal is the CEO of Nordic Bioscience.

Three Factors Increase Risk for Hip Replacement Revision

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SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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Major Finding: Patients had a higher revision risk after a total hip replacement if, at the time of their initial surgery, they had a BMI greater than 30 kg/m2 (OR, 1.5), a cemented femur implant stem (OR, 1.4), a prior contralateral THR (OR, 1.4), previous orthopedic surgery (OR, 1.5), or an age younger than 75 years (OR, 1.5).

Data Source: Case-control study involving 1,672 patients.

Disclosures: The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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Bone Marrow Lesions Change Early in Knee OA

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SAN DIEGO – In the majority of patients with knee osteoarthritis, the baseline volumes of associated bone marrow lesions change substantially within 6 to 12 weeks of diagnosis, judging from the findings of an ongoing drug study.

The findings suggest that volume changes – either decreases or increases as determined by magnetic resonance imaging – may help assess short-term fluctuations in joint damage.

"I think this may allow trials to be done with relatively smaller numbers of patients and briefer follow-ups," said the study’s lead author Dr. David Felson, professor of medicine and epidemiology at both Boston University and the University of Manchester (England).

A rapid marker for disease progress would be welcome; osteoarthritis (OA) is generally considered a slowly evolving disease "with glacial changes in cartilage morphology necessitating trials of potential treatments lasting 1-2 years," Dr. Felson said at the World Congress on Osteoarthritis.

"To the extent that they could be regarded as treatment targets, trials testing [bone marrow lesion] effects could avoid the usual prolonged structure modification trials," he said.

Bone marrow lesions (BMLs) are ill-defined, hyperintense lesions in subcortical bone detected during water-sensitive, fat-suppressed MRIs. Their presence indicates local bone damage and microfractures.

Recently, larger BMLs have been correlated with worse knee pain. Lesions have also been related to malalignment, risk of overlying cartilage loss, OA progression, and poor outcomes, Dr. Felson said.

He and his colleagues used axial and sagittal MRIs to assess BML volumes in patients with painful patellofemoral at baseline, 6, and 12 weeks. The patients were 40-70 years old, with a mean body mass index of about 30 kg/m2. Baseline median BML volumes were a bit over 2,000 mm3.

During the study, 23 of 35 assessed knees had a greater than 50% change in volume. Eight had a greater than 50% change in volume at 6 weeks only, 4 at 12 weeks only, and 11 at both 6 and 12 weeks. BMLs increased or decreased in roughly equal numbers of knees during the study.

Volumes have been known to change at 1 year follow-up; the finding that they do so in as little as 6 weeks is new.

In short, "I think it’s a good marker," Dr. Felson said.

The patients were all participating in a larger treatment trial; the results are still blinded, so it’s not yet possible to correlate treatment outcomes with volume changes.

"Wait for next year," Dr. Felson said.

The congress was sponsored by Osteoarthritis Research Society International. Dr. Felson said he has no disclosures. The study was funded by Arthritis Research UK.

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SAN DIEGO – In the majority of patients with knee osteoarthritis, the baseline volumes of associated bone marrow lesions change substantially within 6 to 12 weeks of diagnosis, judging from the findings of an ongoing drug study.

The findings suggest that volume changes – either decreases or increases as determined by magnetic resonance imaging – may help assess short-term fluctuations in joint damage.

"I think this may allow trials to be done with relatively smaller numbers of patients and briefer follow-ups," said the study’s lead author Dr. David Felson, professor of medicine and epidemiology at both Boston University and the University of Manchester (England).

A rapid marker for disease progress would be welcome; osteoarthritis (OA) is generally considered a slowly evolving disease "with glacial changes in cartilage morphology necessitating trials of potential treatments lasting 1-2 years," Dr. Felson said at the World Congress on Osteoarthritis.

"To the extent that they could be regarded as treatment targets, trials testing [bone marrow lesion] effects could avoid the usual prolonged structure modification trials," he said.

Bone marrow lesions (BMLs) are ill-defined, hyperintense lesions in subcortical bone detected during water-sensitive, fat-suppressed MRIs. Their presence indicates local bone damage and microfractures.

Recently, larger BMLs have been correlated with worse knee pain. Lesions have also been related to malalignment, risk of overlying cartilage loss, OA progression, and poor outcomes, Dr. Felson said.

He and his colleagues used axial and sagittal MRIs to assess BML volumes in patients with painful patellofemoral at baseline, 6, and 12 weeks. The patients were 40-70 years old, with a mean body mass index of about 30 kg/m2. Baseline median BML volumes were a bit over 2,000 mm3.

During the study, 23 of 35 assessed knees had a greater than 50% change in volume. Eight had a greater than 50% change in volume at 6 weeks only, 4 at 12 weeks only, and 11 at both 6 and 12 weeks. BMLs increased or decreased in roughly equal numbers of knees during the study.

Volumes have been known to change at 1 year follow-up; the finding that they do so in as little as 6 weeks is new.

In short, "I think it’s a good marker," Dr. Felson said.

The patients were all participating in a larger treatment trial; the results are still blinded, so it’s not yet possible to correlate treatment outcomes with volume changes.

"Wait for next year," Dr. Felson said.

The congress was sponsored by Osteoarthritis Research Society International. Dr. Felson said he has no disclosures. The study was funded by Arthritis Research UK.

SAN DIEGO – In the majority of patients with knee osteoarthritis, the baseline volumes of associated bone marrow lesions change substantially within 6 to 12 weeks of diagnosis, judging from the findings of an ongoing drug study.

The findings suggest that volume changes – either decreases or increases as determined by magnetic resonance imaging – may help assess short-term fluctuations in joint damage.

"I think this may allow trials to be done with relatively smaller numbers of patients and briefer follow-ups," said the study’s lead author Dr. David Felson, professor of medicine and epidemiology at both Boston University and the University of Manchester (England).

A rapid marker for disease progress would be welcome; osteoarthritis (OA) is generally considered a slowly evolving disease "with glacial changes in cartilage morphology necessitating trials of potential treatments lasting 1-2 years," Dr. Felson said at the World Congress on Osteoarthritis.

"To the extent that they could be regarded as treatment targets, trials testing [bone marrow lesion] effects could avoid the usual prolonged structure modification trials," he said.

Bone marrow lesions (BMLs) are ill-defined, hyperintense lesions in subcortical bone detected during water-sensitive, fat-suppressed MRIs. Their presence indicates local bone damage and microfractures.

Recently, larger BMLs have been correlated with worse knee pain. Lesions have also been related to malalignment, risk of overlying cartilage loss, OA progression, and poor outcomes, Dr. Felson said.

He and his colleagues used axial and sagittal MRIs to assess BML volumes in patients with painful patellofemoral at baseline, 6, and 12 weeks. The patients were 40-70 years old, with a mean body mass index of about 30 kg/m2. Baseline median BML volumes were a bit over 2,000 mm3.

During the study, 23 of 35 assessed knees had a greater than 50% change in volume. Eight had a greater than 50% change in volume at 6 weeks only, 4 at 12 weeks only, and 11 at both 6 and 12 weeks. BMLs increased or decreased in roughly equal numbers of knees during the study.

Volumes have been known to change at 1 year follow-up; the finding that they do so in as little as 6 weeks is new.

In short, "I think it’s a good marker," Dr. Felson said.

The patients were all participating in a larger treatment trial; the results are still blinded, so it’s not yet possible to correlate treatment outcomes with volume changes.

"Wait for next year," Dr. Felson said.

The congress was sponsored by Osteoarthritis Research Society International. Dr. Felson said he has no disclosures. The study was funded by Arthritis Research UK.

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Bone Marrow Lesions Change Early in Knee OA
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Bone Marrow Lesions Change Early in Knee OA
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knee osteoarthritis, bone marrow lesions, magnetic resonance imaging, joint damage, Dr. David Felson, OA, Congress on Osteoarthritis, BMLs, subcortical bone,
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knee osteoarthritis, bone marrow lesions, magnetic resonance imaging, joint damage, Dr. David Felson, OA, Congress on Osteoarthritis, BMLs, subcortical bone,
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FROM THE WORLD CONGRESS ON OSTEOARTHRITIS

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Major Finding: Twenty-three of 35 (66%) OA knees had a greater than 50% change in bone marrow lesion volume within 12 weeks.

Data Source: MRI assessment of patients with patellofemoral OA of the knee at baseline, 6, and 12 weeks

Disclosures: Dr. Felson said he has no disclosures. The study was funded by Arthritis Research UK.