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

Study Overview
=================
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.

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

Conditions
-----------------
Meniscus Tear, Tibial, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: arthroscopic partial meniscectomy
* Other: Physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic partial meniscectomy<br>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<br>* 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.<br>* Other names: APM;|
| Other: Physical therapy<br>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<br>* 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.<br>* 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 |