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

NCT ID: NCT05068843

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-13
• Study Completion Date: 2022-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

arthroscopic partial meniscectomy

Intervention Type: 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.

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.

Group Type: OTHER

Physical therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Other Intervention Names

meniscal surgery; APM; exercise therapy

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Rudolf W Poolman, MD PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id