Knee Osteotomy Associated With Allograft Meniscus Transplantation
Italy52 participantsStarted 2023-08-30
Plain-language 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.
Who can participate
Age range20 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged between 20 and 60 years;
✓. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°);
✓. 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
Exclusion criteria
✕. 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;
What they're measuring
1
IKDC-Subjective Score (Subjective International Knee Documentation Committee)