Repair Augmentation of Unstable, Complete Vertical Meniscal Tears With Bone Marrow Venting Procedure: A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

Abstract

Purpose: To compare the effectiveness and safety of meniscal repair in 2 groups of patients: meniscal repair with biological augmentation using a bone marrow venting procedure (BMVP) of the intercondylar notch versus meniscal repair only.

Methods: This single-center, prospective, randomized, double-blind, placebo-controlled, parallel-arm study included 40 patients (21 menisci in control, 23 in BMVP group) with complete vertical meniscus tears. Patients underwent all-inside and outside-in meniscal repair and a concomitant BMVP of the intercondylar notch or meniscal repair alone during an index arthroscopy. The primary endpoint was the rate of meniscus healing in the 2 groups assessed during a second-look arthroscopy (at week 35). The secondary endpoints were changes in the International Knee Documentation Committee score, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, and visual analog scale in the 2 groups at 30 months.

Results: After 36 weeks, the meniscus healing rate was significantly higher in the BMVP-treated group than in the control group (100% vs. 76%, P = .0035). Functional outcomes were significantly better 30 months after treatment than at baseline in both groups. The International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, and visual analog scale scores were significantly better in the BMVP-treated group than in the control group. No adverse events were reported during the study period.

Conclusions: Our blinded, prospective, randomized, controlled trial on the role of BMVP augmentation in meniscus repair, indicates that BMVP augmentation results in a significant improvement in the rate of meniscus healing (100% vs. 76%, P = .0035). The risk of adverse events related to augmentation with BMVP of the arthroscopic meniscal repair is very low.

Level of evidence: Level I, randomized controlled trial.

Trial registration: ClinicalTrials.gov NCT02323490.