Knee Osteotomy Associated With Allograft Meniscus Transplantation
Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation
Istituto Ortopedico Rizzoli
52 participants
Aug 30, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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;
- 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 Criteria9
- 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.
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Interventions
Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.
Knee osteotomy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05840887