NCT05840887

Knee Osteotomy Associated With Allograft Meniscus Transplantation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with single-compartment arthritic pathology of the knee, axial deviation and meniscal deficit, for whom a surgical indication of corrective osteotomy is placed, will be recruited into the study. Enrollment takes place during hospitalization and is by the physician. All patients will undergo a knee osteotomy to achieve proper alignment of the lower limb and an arthroscopic procedure to macroscopically verify the status of the cartilage and menisci, with associated minor procedures for surgical cleanup when necessary. After intraoperative confirmation of inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment) all patients will undergo synovial biopsy and synovial fluid sampling, half of the patients will also undergo arthroscopic homologous meniscus transplantation. Clinical, biomechanical and biological evaluations will be performed: Clinical evaluation of the patient will be done through validated questionnaires before surgery and at 1-3-6-12 months. These will document subjective clinical improvement, functional measurements, and imaging using radiographs as per clinical practice and MRI. Pitch Analysis will be used for biomechanical assessments, and will be performed before surgery and at 12-month follow-up after surgery for all patients enrolled in the two groups. basal inflammation will be assessed on synovial tissue and synovial fluid samples collected after intraoperative confirmation of patient inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment). Serum/plasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up.

Conditions

• Malalignment, Bone
• Osteoarthritis, Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-05-03
• Last updated: 2025-12-04

Locations

1 site across 1 country: Italy