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

Not Applicable

Completed

• Conditions: Meniscus Tear, Tibial; Osteoarthritis, Knee
• Interventions: Other: Physical therapy; Procedure: arthroscopic partial meniscectomy

• Registration Number: NCT05068843
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-13
• Primary Completion: 2020-11-01
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Study Completion: 2022-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physical therapy	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.
Arthroscopic partial meniscectomy	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

Primary Outcome Measures

Name	Time	Method
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire	60 months	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic Knee osteoarthritis	60 months	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.
Symptomatic knee osteoarthritis (OA)	60 months	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.
Patient reported knee pain during weight bearing	60 months	Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100
Patient reported quality of life	60 months	Quality of life assessed by the Euroqol 5 diminesions 5 Levels