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

Onze Lieve Vrouwe Gasthuis0 sites321 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 26, 2017

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Onze Lieve Vrouwe Gasthuis

•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.

•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.