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COMPLETED
NCT07858669
NA

Arthroscopic Capsulodesis Decreases Meniscal Extrusion at 1 Year Follow up When Combined With Transtibial Pull Out Repair of Posteromedial Root Lesion. A Prospective Randomized Study

Sponsor: Institut Català de Traumatologia i Medicina de l'Esport

View on ClinicalTrials.gov

Summary

Primary objective is to compare isolated single tunnel transtibial pull out posterior medial meniscus root repair (PMMRR) with the same repair augmented by arthroscopic capsulodesis. Study design: Prospective randomized controlled trial. The study will be registered in the international Clinical Trials registry. Inclusion criteria: symptomatic isolated PMMRT confirmed by MRI, type 2 or type 4 tears according to the LaPrade classification, age between 18 and 65 years, neutral coronal alignment (mechanical axis deviation \<4° varus), as confirmed on standardized full-length standing radiographs. Exclusion criteria: previous ipsilateral meniscal or ligament surgery, body mass index (BMI) \>35 kg/m², advanced osteoarthritis (Kellgren-Lawrence grade III-IV), inflammatory arthropathy, metabolic bone disease, spontaneous osteonecrosis of the knee or inability to adhere to the standardized postoperative rehabilitation protocol. Randomization: Eligible patients will be randomized in a 1:1 ratio to either isolated posterior medial meniscus root repair group (PMMRR) or PMMRR augmented with arthroscopic capsulodesis group, performed centrally by an independent statistician using a computer-generated randomization sequence with variable block sizes of 4 to 6. Image control with MRI will be performed at 3, 6 and 12 month and evaluated by two fellowship-trained musculoskeletal radiologists blinded to treatment allocation, clinical information, and temporal sequence of scans.The primary endpoint (medial meniscal extrusion at 12 months) will be analyzed using analysis of covariance (ANCOVA), with treatment group as the fixed effect, baseline extrusion as a covariate, and study center included as a random effect to account for clustering.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2024-05-21

Completion Date

2026-09-25

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

PROCEDURE

Meniscal root repair

A dedicated tibial root repair guide will be used to create a single anatomic 3.2mm transtibial tunnel from the anterolateral tibial cortex to the native posterior root attachment site. Two nonabsorbable high strength No. 2 sutures will be passed through the meniscal posterior horn in a cinch-loop stitch configuration, retrieved via the tibial tunnel, and securely tied over a cortical fixation button on the anterolateral tibial cortex.

PROCEDURE

Meniscal root repair

Capsulodesis will be performed immediately after root repair. A single 2.4-mm tibial tunnel drilled from the anteromedial tibial cortex in an oblique direction, exiting at the edge of the medial tibial plateau. The capsule and adjacent meniscal tissue captured using spinal needles loaded with No. 2 polydioxanone sutures in an outside-in fashion. Two fixation points established: the first at the meniscal body and the second approximately 1 cm posterior to the initial capture site. Suture exchanged. Suture limbs tied over a cortical fixation button

Locations (1)

Hospital Universitario Dexeus, Barcelona, Barcelona 08028

Barcelona, Spain