Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy in older Patients. A Randomized Controlled Trial.

Completed

• Conditions: meniscal tear; non-mechanical meniscal tears in older patients; 10023213; 10005944

• Registration Number: NL-OMON41646
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2016-09-21
• Study Completion: 2017-09-26
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 321

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome will be change in physical function from baseline to 2 years<br /><br>measured by the International Knee Documentation Committee (IKDC) 'Subjective<br /><br>Knee Form', which has been validated for meniscal injuries (18).<br /><br>In addition, we will perform an economic analysis alongside the RCT from a<br /><br>societal perspective and a budget impact analysis from societal, government and<br /><br>insurer perspective.</p><br>