Back to resultsArthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.
Primary Purpose
Meniscus Tear, Tibial, Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
arthroscopic partial meniscectomy
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Meniscus Tear, Tibial
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Arthroscopic partial meniscectomy
Physical therapy
Arm 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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Patient reported knee pain during weight bearing
Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100
Patient reported quality of life
Quality of life assessed by the Euroqol 5 diminesions 5 Levels
Full Information
NCT ID
NCT05068843
First Posted
February 23, 2021
Last Updated
September 24, 2021
Sponsor
Onze Lieve Vrouwe Gasthuis
1. Study Identification
Unique Protocol Identification Number
NCT05068843
Brief Title
Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2013 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouwe Gasthuis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tear, Tibial, Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic partial meniscectomy
Arm Type
Active Comparator
Arm 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
Arm Title
Physical therapy
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
arthroscopic partial meniscectomy
Other Intervention Name(s)
meniscal surgery, APM
Intervention Description
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
Other
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
Description
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.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Radiographic Knee osteoarthritis
Description
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.
Time Frame
60 months
Title
Symptomatic knee osteoarthritis (OA)
Description
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.
Time Frame
60 months
Title
Patient reported knee pain during weight bearing
Description
Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100
Time Frame
60 months
Title
Patient reported quality of life
Description
Quality of life assessed by the Euroqol 5 diminesions 5 Levels
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
available on request
Learn more about this trial
Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.
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