Knee osteotomy with meniscus transplantation for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Alessandro Di Martino, MD
• Email: roberta.licciardi@ior.it
• Phone: 6366567

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SVF cellular mix, secretome, and knee response in osteoarthritis

  This study tests the cellular composition and secretome of research-only adipose-derived SVF in adults with knee OA who are already planned to receive an autologous SVF injection as part of their care.

  Recruiting Yonsei University · Seoul · NCT07898501

• Effect of a Resistance Exercise Program on IGF-1 Levels in Knee Osteoarthritis

  A structured 8-week resistance exercise program is being tested to see if it changes blood IGF-1 levels and improves knee OA symptoms in adults with knee OA and metabolic traits.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07890155

• 2-mm subchondral drilling vs sequential 4-mm and 2-mm drilling during CARTISTEM implantation for knee cartilage defects

  This study tests whether drilling the knee with a 2-mm drill alone works as well as sequential 4-mm then 2-mm drilling when combined with CARTISTEM treatment for medial knee cartilage defects.

  Recruiting Yonsei University · Seoul · NCT07881445

• Undenatured Type II Collagen for Knee Osteoarthritis Pain (Three-Arm Trial)

  This study tests whether taking undenatured type II collagen capsules once daily for 4 months can reduce knee pain in adults with knee osteoarthritis, compared with two collagen formulations and a placebo.

  Recruiting Universidad Católica San Antonio de Murcia · Murcia, Murcia · NCT07870967

• Serum Fetuin‑A and COMP levels in knee osteoarthritis

  This study tests whether levels of Fetuin‑A and COMP in the blood relate to how severe knee osteoarthritis is in patients compared with healthy volunteers.

  Recruiting Antalya Training and Research Hospital · Antalya · NCT07706569

• Pain relief for knee osteoarthritis: a 2nd phase study of LY4065967 vs placebo

  Researchers are testing whether LY4065967 can help reduce knee pain from osteoarthritis in adults, compared with placebo.

  Recruiting at 36 sites Phase 2 Eli Lilly and Company · Birmingham, Alabama and 35 other locations · NCT07641517

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.