Meniscus Tear, Tibial, Osteoarthritis, Knee
Conditions
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.
Interventions
PROCEDUREarthroscopic 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.
OTHERPhysical 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.
Sponsors
Onze Lieve Vrouwe Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Knee osteoarthritis | 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. |
| Symptomatic knee osteoarthritis (OA) | 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. |
| Patient reported knee pain during weight bearing | 60 months | Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100 |
| Patient reported quality of life | 60 months | Quality of life assessed by the Euroqol 5 diminesions 5 Levels |
Outcome results
None listed