Actively Recruiting
Knee Osteotomy Associated With Allograft Meniscus Transplantation
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-04
52
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Knee Osteotomy Associated With Allograft Meniscus Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged between 20 and 60 years
- Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade 3)
- Surgical indication of corrective osteotomy (axial deviation of lower extremities > 56)
- Meniscal deficit of the compartment affected by the overload due to malalignment
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
- Signature of informed consent
You will not qualify if you...
- Patients who are incapacitated or have neurological disorders that may invalidate the research protocol
- Diagnosis of neoplastic diseases
- 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
- Patients with uncontrolled diabetes mellitus
- Patients with uncontrolled thyroid metabolic disorders
- Patients abusing alcoholic beverages, drugs or medications
- Body Mass Index > 40
- Pregnancy or lactation status or intention to become pregnant during the period of study participation
- Patients undergoing knee surgery in the previous 12 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
A
Alessandro Di Martino, MD
CONTACT
R
Roberta Licciardi, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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