Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial

Abstract

Importance: Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears.

Objective: To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears.

Design, setting, and participants: Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017).

Interventions: Three hundred twenty-one participants were randomly assigned to APM (n = 159) or a predefined PT protocol (n = 162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises.

Main outcomes and measures: The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided α of .025. The primary analysis followed the intention-to-treat principle.

Results: Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -∞ to 6.5; P value for noninferiority = .001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events.

Conclusions and relevance: Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.

Trial registration: ClinicalTrials.gov Identifier: NCT01850719.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs van de Graaf, Noorduyn, Willigenburg, Butter, and Poolman reported receiving grants from the Netherlands Organisation for Health Research and Development (ZonMw), Achmea Healthcare Foundation (Stichting Achmea Gezonheidszorg fonds), and the Foundation of Medical Research OLVG, Amsterdam, the Netherlands. Dr Mol reported support from a National Health and Medical Research Council Practitioner Fellowship (GNT1082548) and reported consultancy for ObsEva, Merck, and Guerbe. Dr Saris reported receiving personal fees from Cartiheal and Vericel and grants from Smith & Nephew and Ivy Sports. Dr Poolman also reported board membership with the NOV-Dutch Orthopaedic Society and receiving grants from Link/Lima, Stryker, and McMaster University and personal fees from British Medical Journal and Link. No other disclosures were reported.

Figures

Figure 1.. Flow of Patients Through the ESCAPE Trial

aThe number of patients screened for eligibility was not available. bMissing data refer to data that were missing at a specific time point, while patients remained available for the remaining follow-up times. cLoss to follow-up refers to actual dropout from the study; eg, patients who did not participate at any of the remaining time points (cumulative numbers are total number of dropouts). dCumulative number of delayed APM refers to total number of participants from the physical therapy group who received delayed APM from baseline until that follow-up.

Figure 2.. Distribution of International Knee Documentation Committee (IKDC) Score of Knee Function

The figure represents the results of the primary outcome knee function on the IKDC (range, 0 to 100; from worse to best) for intention-to-treat analysis. The data represent actual patient data at each time. In each comparison, the box indicates the range between the 25th and 75th percentile, with the median indicated as a horizontal line within the box. The whiskers extend to the upper and lower adjacent values, the most extreme values that are within 1.5 × interquartile range (IQR) beyond the 26th and 75th percentiles. Circles indicate points beyond these values. The median IKDC data are in eTable 5 in Supplement 2.