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RECRUITING
NCT05840887
NA

Knee Osteotomy Associated With Allograft Meniscus Transplantation

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

Summary

This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 allocation. The main objective of the BIOMAT project is to demonstrate, through an RCT, whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment. Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration.

Official title: Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2023-08-30

Completion Date

2026-06

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

PROCEDURE

Knee osteotomy associated with meniscal allograft transplantation

Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.

PROCEDURE

Knee osteotomy

Knee osteotomy

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy