Knee Osteotomy Associated With Allograft Meniscus Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
Qualifiers
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 > 5°);
Meniscal deficit of the compartment affected by the overload due to malalignment;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Knee osteotomy associated with meniscal allograft transplantation
- Knee osteotomy
Treatment groups
52 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov