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

NCT05068843 | Completed

• 1 other identifier: 3
• Study Type: interventional
• Target: 321
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meniscus Tear, Tibial; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiographic Knee osteoarthritis

  60 months

• Symptomatic knee osteoarthritis (OA)

  60 months

• Patient reported knee pain during weight bearing

  60 months

• Patient reported quality of life

  60 months

Study Arms (2)

Arthroscopic partial meniscectomy

ACTIVE COMPARATOR

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

Physical therapy

OTHER

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

Interventions

arthroscopic partial meniscectomy PROCEDURE

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.

Also known as: meniscal surgery, APM

Arthroscopic partial meniscectomy

Physical therapy OTHER

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.

Also known as: exercise therapy

Physical therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

MeSH Terms

Conditions

Tibial Meniscus Injuries; Osteoarthritis, Knee

Interventions

Physical Therapy Modalities; Exercise Therapy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: October 6, 2021
• Study Start: July 13, 2013
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share