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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068843
• Other study ID #: 3
• Status: Completed
• Phase: N/A
• Start date: July 13, 2013
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2023
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniscus Tear, Tibial
• Osteoarthritis, Knee
• Tibial Meniscus Injuries

Intervention

Procedure:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiographic Knee osteoarthritis	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.	60 months
Secondary	Symptomatic knee osteoarthritis (OA)	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.	60 months
Secondary	Patient reported knee pain during weight bearing	Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100	60 months
Secondary	Patient reported quality of life	Quality of life assessed by the Euroqol 5 diminesions 5 Levels	60 months