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Reference: JAMA. 2018 Oct 2;320(13):1328 (level 2 [mid-level] evidence)
Arthroscopic surgery for knee pathology is the most commonly performed orthopedic surgery worldwide despite growing evidence from multiple clinical trials questioning its efficacy in a variety of clinical settings. A recently published multicenter randomized noninferiority trial in the Netherlands compared early meniscectomy to physical therapy for adults age 45 to 70 with knee pain and non-obstructive meniscal tear found on MRI. The primary outcome was change in patient-reported knee function from baseline over 24 months (included data from all interval time points) based on the Subjective Knee Form of the International Knee Documentation Committee (IKDC) with scale 0-100, where 100 = no functional limitation. Researchers randomized 321 patients to either arthroscopic partial meniscectomy (APM) or sixteen 30-minute sessions of physical therapy (PT) over 8 weeks. Patients in the APM group did not undergo postoperative PT unless indicated by the surgeon for treatment failure or functional decline.
Participants in each group were similar in age (mean 57 years), body mass index (mean 27), and comorbidities. Most had “doubtful” to “minimal” osteoarthritis on plain radiography. Loss to follow up was lower than predicted at 10% and crossover rates in the PT group to APM was 29% (45 of 141 patients). Both groups had an overall improvement from baseline during the 2 years of follow up. In both the as-treated and intention to treat analyses, PT met the predefined noninferiority margin when data from 3, 6, 12, and 24 months were combined. However, PT did not meet the noninferiority threshold at 12 or 24 months when taken individually.
It is worth pointing out that the language describing the primary outcome was changed from “change from baseline to 24-month follow-up” to “change from baseline over 24-month follow-up”.This is important because the change in knee function from baseline to 24 month follow-up did not meet noninferiority criteria for PT based on the predefined one-tailed analysis (p
< 0.025). Rather than demonstrating overall noninferiority at 24 months as reported, these data may actually point to noninferiority only up until 6 months, which overlaps with the post-op period of the APM group. However, even when the difference was not within the noninferiority margin, the difference was less than the prespecified minimal clinically important difference of 8 points in the IKDC score. At follow up, the greatest within group difference over the 24 month time interval in IKDC score was only 5.7 points. These findings are consistent with the METEOR trial that found starting with physical therapy and having surgery only if that failed was as effective as immediate surgery in patients with osteoarthritis of the knee. In addition, the FIDELITY trial compared arthroscopic surgery to sham surgery with exercises in both groups after the procedure and found no significant differences in outcomes at 12 months, which further questions the value of surgery.
Focus Point: Starting with physical therapy and offering surgery to those who are not improving may be a reasonable approach.
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DynaMed Plus EBM Focus Editorial Team
This EBM Focus was written by Carina Brown, MD, Faculty Development and Information Mastery Fellow and Clinical Instructor at the University of Virginia. Edited by Alan Ehrlich, MD, Executive Editor at DynaMed Plus and Associate Professor in Family Medicine at the University of Massachusetts Medical School and Katharine DeGeorge, MD, MS, Assistant Professor in Family Medicine at the University of Virginia and Clinical Editor at DynaMed Plus.