NCT05840887

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

Recruiting now NA Last updated 3 December 2025

What this trial tests

NA trial testing Knee osteotomy associated with meniscal allograft transplantation in Malalignment, Bone in 52 participants. Currently enrolling.

Timeline

30 August 2023

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	30 August 2023
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across Italy

Drugs / interventions tested

• Knee osteotomy associated with meniscal allograft transplantation
• Knee osteotomy

Conditions studied

• Malalignment, Bone — all drugs for Malalignment, Bone →
• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 20 to 60, any sex, with Malalignment, Bone or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• IKDC-Subjective Score (Subjective International Knee Documentation Committee)
  Time frame: 12 months follow-up
  This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Knee osteotomy combined with meniscal allograft transplantation versus knee osteotomy alone in patients with unicompartmental knee osteoarthritis: a prospective double-blind randomised controlled trial protocol.
   Zanasi L, Boffa A, De Marziani L, Lisignoli G, et al · · 2024 · PMID 39672576 · DOI 10.1136/bmjopen-2024-087552