Knee Osteotomy Associated With Allograft Meniscus Transplantation
Eligible age
20–60 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Istituto Ortopedico Rizzoli
You may qualify if…
- ✓ 1. Male or female patients aged between 20 and 60 years;
- ✓ 2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
- ✓ 3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°);
- ✓ 4. Meniscal deficit of the compartment affected by the overload due to malalignment;
- ✓ 5. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
- ✓ 6. Signature of informed consent
You may not qualify if…
- ✕ 1. Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
- ✕ 2. Diagnosis of neoplastic diseases;
- ✕ 3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
- ✕ 4. Patients with uncontrolled diabetes mellitus;
- ✕ 5. Patients with uncontrolled thyroid metabolic disorders;
- ✕ 6. Patients abusing alcoholic beverages, drugs or medications;
- ✕ 7. Body Mass Index \> 40;
- ✕ 8. Pregnancy or lactation status or intention to become pregnant during the period of study participation;
Source: ClinicalTrials.gov · NCT05840887 · last updated 2025-12-04