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โ† Trials
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Knee Osteotomy Associated With Allograft Meniscus Transplantation

RecruitingNAAges 20 Years - 60 YearsAllIstituto Ortopedico Rizzoli
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female patients aged between 20 and 60 years; 2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade โ‰ค 3); 3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5ยฐ); 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 Exclusion Criteria: 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; 9. Patients undergoing knee surgery in the previous 12 months.
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What it tests

  • Knee osteotomy associated with meniscal allograft transplantation
  • Knee osteotomy
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Where

1 site
Istituto Ortopedico Rizzoli
Bologna, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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