NCT05840887 Knee Osteotomy Associated With Allograft Meniscus Transplantation
| NCT ID | NCT05840887 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Malalignment, Bone |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2023-08-30 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2023-08-30 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05840887 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Malalignment, Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05840887 currently recruiting?
Yes, NCT05840887 is actively recruiting participants. Contact the research team at roberta.licciardi@ior.it for enrollment information.
Where is the NCT05840887 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT05840887 clinical trial?
NCT05840887 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 52 participants.