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

O

Onze Lieve Vrouwe Gasthuis

Status

Completed

Conditions

Meniscus Tear, Tibial
Osteoarthritis, Knee

Treatments

Other: Physical therapy
Procedure: arthroscopic partial meniscectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

321 participants in 2 patient groups

Arthroscopic partial meniscectomy
Active Comparator group
Description:
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
Treatment:
Procedure: arthroscopic partial meniscectomy
Physical therapy
Other group
Description:
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.
Treatment:
Other: Physical therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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