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Clinical Trials/NCT05068843
NCT05068843
Completed
Not Applicable

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

Onze Lieve Vrouwe Gasthuis0 sites321 target enrollmentJuly 13, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Tear, Tibial
Sponsor
Onze Lieve Vrouwe Gasthuis
Enrollment
321
Primary Endpoint
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 13, 2013
End Date
May 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Onze Lieve Vrouwe Gasthuis
Responsible Party
Principal Investigator
Principal Investigator

Rudolf W Poolman, MD PhD

Principal Investigator

Onze Lieve Vrouwe Gasthuis

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;

Outcomes

Primary Outcomes

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

  • 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)

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