Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.

Arthroscopic Partial Meniscectomy Versus Physical Therapy for Patients Over 45 Years With a Meniscal Tears: 5-year Follow-up of the ESCAPE Trial

Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.

With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Meniscus Tear, Tibial
• Intervention / Treatment: Procedure: arthroscopic partial meniscectomy; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear

Exclusion Criteria:

• Knee locking or trauma leading to acute surgery;

  ▸ Associated injuries on the index knee consisting of:

• Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
• Posterior cruciate ligament tear,
• OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,

• An injury to the lateral or posterolateral ligament complex with significant laxity;

  • Previous knee surgery on the index knee (with the exception of diagnostic arthroscopy);
  • Tumour that is suspected of malignancy, detectable on MRI;
  • Obesity with a body mass index >35;
  • American Society of Anesthesiologists (ASA) class 4 or 5 patients;
  • General disease that effects physical function or systemic medication/abuse of steroids;
  • Any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to MRI or surgery;
  • Drugs or alcohol abuse;
  • Patients unable to fill out the Dutch questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arthroscopic partial meniscectomy; In the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy (APM) within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present. Other Names: APM meniscal surgery surgery	Procedure: arthroscopic partial meniscectomy; In the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present.; Other Names: APM; meniscal surgery
Other: Physical therapy; The physical therapy program consisted of a physical therapist-led incremental exercise program containing of coordination/balance, closed kinetic chain strengths and cardiovascular exercises (see Appendix 1). The program was designed for 8 weeks with a total of 16 treatment sessions, each with a duration of 30 minutes. All 16 sessions were reimbursed. If knee symptoms persisted following the physical therapy program (e.g., knee pain, limitations in daily activities or mechanical dysfunction ), the patient could attend additional physical therapy sessions (not reimbursed by the study) or have meniscal surgery, depending on a shared decision after consultation with their orthopaedic surgeon.	Other: Physical therapy; The treatment protocol consisted of a physical therapist-led incremental exercise program over a period of eight weeks, containing 16 sessions of 30 minutes each.; Other Names: exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire	Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire to assess patient reported knee functionWe assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Knee osteoarthritis	The OARSI atlas is a semi-quantitative instrument with focus to assess the severity of joint space narrowing and osteophytes in knee OA. We considered radiographic knee OA if any of the follow three criteria were met: 1) Joint space narrowing of grade 2 or higher; 2) sum of osteophyte grades ≥2 or 3) grade 1 joint space narrowing in combination with a grade 1 osteophyte.	60 months
Symptomatic knee osteoarthritis (OA)	Our main outcome is symptomatic knee osteoarthritis (OA). Symptomatic knee OA is a combination of knee OA assessed on radiograph and patient reported frequency of knee pain. We assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.	60 months
Patient reported knee pain during weight bearing	Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100	60 months
Patient reported quality of life	Quality of life assessed by the Euroqol 5 diminesions 5 Levels	60 months

Collaborators and Investigators

• Sponsor: Onze Lieve Vrouwe Gasthuis

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2013
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Tibial Meniscus Injuries
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No