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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Alessandro Di Martino, MD
roberta.licciardi@ior.it
6366567
Backup
Roberta Licciardi, MSc
roberta.licciardi@ior.it
6366567
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 52
Treatments
Experimental: Knee Ostetomy combined with meniscal allograft transplantation
The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.
Active_comparator: Knee Osteotomy
The control group will consist of patients who will perform an isolated osteotomy.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov