Knee osteotomy with meniscus transplantation for knee osteoarthritis

Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation

This study is testing if adding a meniscus transplant to knee surgery helps people with knee osteoarthritis feel better and move easier compared to just the knee surgery alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 20 Years to 60 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT05840887 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining knee osteotomy with meniscal allograft transplantation (MAT) compared to knee osteotomy alone in patients suffering from monocompartmental knee osteoarthritis associated with meniscal insufficiency and malalignment. Patients will undergo a knee osteotomy to correct limb alignment, and half will receive a meniscal transplant during the procedure. Clinical evaluations, including questionnaires and imaging, will be conducted at multiple follow-up points to assess improvements in function and joint health. The study also includes biomechanical assessments and analysis of synovial tissue to understand the treatment's impact on inflammation and cartilage degeneration.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 20 to 60 with single-compartment knee osteoarthritis and meniscal deficits requiring corrective osteotomy.

Not a fit: Patients with severe inflammatory arthritis, uncontrolled diabetes, or significant neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved clinical outcomes and joint preservation for patients with knee osteoarthritis.

How similar studies have performed: Previous studies have shown promising results for similar combined surgical approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients aged between 20 and 60 years;
2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°);
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.

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Alessandro Di Martino, MD

Conditions Malalignment, Bone; Osteoarthritis, Knee; knee osteotomy; MAT; meniscal allograft transplatation