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

Victor A. Van De Graaf* (Corresponding Author), Julia C.A. Noorduyn, Nienke W. Willigenburg, Ise K. Butter, Arthur De Gast, Ben W. Mol, Daniel B.F. Saris, Jos W.R. Twisk, Rudolf W. Poolman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

111 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1328-1337
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume320
Issue number13
DOIs
Publication statusPublished - 2 Oct 2018

Bibliographical note

Funding/Support: This study was funded by the Netherlands Organization for Health Research and Development (in Dutch: ZonMw; grant 837002009), Zilverenkruis Health Insurance (grant Z436), and the Foundation of Medical Research of the OLVG, Amsterdam (grant 15u.025).

Correction: This article was corrected online March 10, 2020, to correct numbers that should have been negative and fix P values in Table 3, as well as fix the number of participants who were available for primary analysis in the physical therapy group in Figure 1. DOI: 10.1001/jama.2018.17900

Data Availability Statement

Data Sharing Statement
van de Graaf. Effect of Early Surgery vs Physical Therapy on Knee
Function Among Patients With Nonobstructive Meniscal Tears. JAMA.
Published October 02, 2018. 10.1001/jama.2018.13308
Data
Data available: Yes
Data types: Other (please specify)
Additional Information: individual patient data meta-analysis
How to access data: The data will be made available for an
international individual patient data meta-analysis
When available: With publication
Supporting Documents
Document types: None
Additional Information
Who can access the data: not applicable
Types of analyses: individual patient data meta-analysis
Mechanisms of data availability: After approval of the proposal and
with a signed data access agreement

Keywords

  • Aged
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Humans
  • Knee Joint
  • Male
  • Meniscectomy
  • Middle Aged
  • Osteoarthritis, Knee
  • Physical Therapy Modalities
  • Recovery of Function
  • Reoperation
  • Severity of Illness Index
  • Tibial Meniscus Injuries

Fingerprint

Dive into the research topics of 'Effect of Early Surgery vs Physical Therapy on Knee Function among Patients with Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial'. Together they form a unique fingerprint.

Cite this