meniscal tear non-mechanical meniscal tears in older patients
Conditions
Interventions
Intervention group:
Arthroscopic partial APM is performed within 4 weeks in day-care by an
orthopaedic surgeon experienced in arthroscopic surgery, or by a resident
skilled in athroscopic knee surge
member of the research group) who earned his PhD degree in the field of the
anterior cruciate ligament and is specialized on the knee.
After completion of the PT-sessions, patients will visit the ou
Sponsors
Onze Lieve Vrouwe Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients between 45 and 70 years of age at presentation. 2) A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic anterior cruciate ligament (ACL) injury or a asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift). 3) Mental Competence. 4) Willingness to comply with follow-up schedule. 5) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Knee locking or trauma leading to acute surgery. 2) One of the following associated injuries on the index knee: a. A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI; b. A complete PCL injury; c. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray; d. An injury to the lateral/posterolateral ligament complex with significantly increased laxity. 3) A history of knee surgery other than diagnostic arthroscopy on the index knee. 4) Tumors on MRI suspected for a malignancy. 5) Obese patients with BMI > 35. 6) ASA 4-5 (appendix D) patients with can interfere with revalidation. 7) General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout) 8) Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery. 9) Drugs or alcohol abuse. 10) Patients unable to speak or read Dutch.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OUTCOMES: 1) Change in: - General health, measured by RAND-36; - Quality of life, measured by EQ-5D5L; - Pain, measured by the VAS for pain, both in rest and at weight bearing; - Level of activity, measured by Tegner Activity Scale (TAS); - Patient specific complaints measured by the PSC (patient specific complaints) Questionnaire; - Treatment group; number of patients initially treated conservatively, treated secondarily by APM. We will use the EQ-5D5L to measure Quality Adjusted Life Years (QALY). 2) Productivity losses, measured by Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). 3) Participants expectation of treatment and their satisfaction. 4) Physical Examination (PE), consisting of performance on physical tests (squatting with duckwalk, Thessely test, McMurray), the range of motion, joint line tenderness and the existence of hydrops in the knee. 5) Adverse events including: -Minor: prolonged synovial fluid leakage from arthroscopy portals and bleeding -Moderate: surgical site infection, vascular and neurological damage -Severe: septic arthritis, cardiac events, pulmonary embolism and death Surgical instrument malfunction will be recorded, as well as reoperations including knee arthroplasties and re-hospitalization. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be change in physical function from baseline to 2 years measured by the International Knee Documentation Committee (IKDC) 'Subjective Knee Form', which has been validated for meniscal injuries (18). In addition, we will perform an economic analysis alongside the RCT from a societal perspective and a budget impact analysis from societal, government and insurer perspective. | — |
Countries
Netherlands
Outcome results
None listed