User login
according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.
Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.
“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.
The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.
Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
Assembling the DREAM team
The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.
In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female
Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.
Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
No gain in pain
The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.
“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”
Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).
Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).
While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.
There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
Views on results
The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.
During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.
She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”
Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”
Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.
“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.
The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.
The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.
according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.
Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.
“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.
The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.
Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
Assembling the DREAM team
The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.
In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female
Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.
Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
No gain in pain
The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.
“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”
Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).
Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).
While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.
There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
Views on results
The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.
During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.
She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”
Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”
Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.
“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.
The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.
The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.
according to the results of the randomized controlled DREAM trial presented at the OARSI 2022 World Congress.
Indeed, similar clinically relevant improvements in knee pain, function, and quality of life at 12 months were seen among participants in both study arms.
“Our results highlight that decisions on surgery or nonsurgical treatment must depend on preferences and values and needs of the individuals consulting their surgeon,” Søren T. Skou, PT, MSc, PhD, reported during one of the opening sessions at the meeting sponsored by the Osteoarthritis Research Society International.
The lack of superiority was contrary to the expectations of the researchers who hypothesized that early surgical intervention in adults aged between 18 and 40 years would be more beneficial than an active rehabilitation program with later surgery if needed.
Although the results do tie in with the results of other trials and systematic reviews in older adults the reason for looking at young adults specifically, aside from the obvious differences and the origin of meniscal tears, was that no study had previously looked at this population, Dr. Skou explained.
Assembling the DREAM team
The DREAM (Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults) trial “was a collaborative effort among many clinicians in Denmark – physical therapists, exercise physiologists, and surgeons,” Dr. Skou observed.
In total, 121 adults with MRI-verified meniscal tears who were eligible for surgery were recruited and randomized to either the early meniscal surgery group (n = 60) or to the exercise and education group (n = 61). The mean age was just below 30 years and 28% were female
Meniscal surgery, which was either an arthroscopic partial meniscectomy or meniscal repair, was performed at seven specialist centers. The exercise and education program was delivered by trained physical therapists working at 19 participating centers. The latter consisted of 24 sessions of group-based exercise therapy and education held over a period of 12 weeks.
Participants randomized to the exercise and education arm had the option of later meniscal surgery, with one in four eventually undergoing this procedure.
No gain in pain
The primary outcome measure was the difference in the mean of four of the subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) from baseline to 12-month assessment. The KOOS4 looks at knee pain, symptoms, function in sport and recreation, and quality of life.
“We considered a 10-point difference between groups as clinically relevant,” said Dr. Skou, but “adjusting for the baseline differences, we found no [statistical] differences or clinically relevant differences between groups.”
Improvement was seen in both groups. In an intention-to-treat analysis the KOOS4 scores improved by 19.2 points and 16.4 points respectively in the surgery and exercise and education groups, with a mean adjusted difference of 5.4 (95% confidence interval, –0.7 to 11.4). There was also no difference in a per protocol analysis, which considered only those participants who received the treatment strategy they were allocated (mean adjusted difference, 5.7; 95% CI, –0.9 to 12.4).
Secondary outcomes were also similarly improved in both groups with clinically relevant increases in all four KOOS subscale scores and in the Western Ontario Meniscal Evaluation Tool (WOMET).
While there were some statistical differences between the groups, such as better KOOS pain, symptoms, and WOMET scores in the surgery group, these were felt unlikely to be clinically relevant. Likewise, there was a statistically greater improvement in muscle strength in the exercise and education group than surgery group.
There was no statistical difference in the number of serious adverse events, including worsening of symptoms with or without acute onset during activity and lateral meniscal cysts, with four reported in the surgical group and seven in the exercise and education group.
Views on results
The results of the trial, published in NEJM Evidence, garnered attention on Twitter with several physiotherapists noting the data were positive for the nonsurgical management of meniscal tears in younger adults.
During discussion at the meeting, Nadine Foster, PhD, NIHR Professor of Musculoskeletal Health in Primary Care at Keele (England) University, asked if a larger cohort might not swing the results in favor of surgery.
She said: “Congratulations on this trial. The challenge: Your 95% CIs suggest a larger trial would have concluded superiority of surgery?”
Dr. Skou responded: “Most likely the true difference is outside the clinically relevant difference, but obviously, we cannot exclude that there is actually a clinically relevant difference between groups.”
Martin Englund, MD, Phd, of Lund (Sweden) University Hospital in Sweden, pointed out that 16 patients in the exercise and education group had “crossed over” and undergone surgery. “Were there any differences for those patients?” he asked.
“We looked at whether there was a difference between those – obviously only having 16 participants, we’re not able to do any statistical comparisons – but looking just visually at the data, they seem to improve to the same extent as those undergoing nonsurgical only,” Dr. Skou said.
The 2-year MRI data are currently being examined and will “obviously also be very interesting,” he added.
The DREAM trial was funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand. Dr. Skou had no financial or other conflicts of interest to disclose.
FROM OARSI 2022