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NCT Number: NCT05068843

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

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.

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Key information

Conditions

Meniscus Tear, Tibial Arthritis Joint Diseases Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Tibial Meniscus Injuries Wounds and Injuries

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: meniscal surgery, APM

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.

Other names: exercise therapy

Primary outcomes

  1. Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire

    Time frame: 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 outcomes

  1. Radiographic Knee osteoarthritis

    Time frame: 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.

  2. Symptomatic knee osteoarthritis (OA)

    Time frame: 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.

  3. Patient reported knee pain during weight bearing

    Time frame: 60 months

    Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100

  4. Patient reported quality of life

    Time frame: 60 months

    Quality of life assessed by the Euroqol 5 diminesions 5 Levels

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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