NCT06597357

Evaluation of Clinical and Radiographic Outcomes of Meniscal Lesion Treatment Using Collagen Scaffolds (CMI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Meniscal lesions represent the most frequently encountered joint pathology in the adult population and can cause pain symptoms, mechanical blockages, and recurrent effusions. The treatment of these lesions has progressively evolved from meniscectomy (removal of the damaged meniscal tissue) to the use of meniscal sutures (where possible) to preserve as much meniscus as possible. Numerous studies have demonstrated a correlation between the amount of meniscus removed and the future onset of osteoarthritis. However, in some cases, especially in the presence of complex and/or chronic lesions, meniscectomy remains the only viable surgical option. Over time, months or years later, a subgroup of patients may develop symptoms such as pain, joint swelling, and mechanical overload of the compartment that underwent meniscectomy, a condition known as post-meniscectomy syndrome..A portion of these patients will later develop knee osteoarthritis and require invasive procedures such as partial or total knee replacement. In an attempt to treat this condition, scaffolds-collagen implants-have been developed and are arthroscopically implanted in the knee with the aim of functionally replacing the tissue removed during surgery. The goal is to reduce the incidence of long-term osteoarthritis and, consequently, the need for more invasive procedures. To date, no study has definitively demonstrated the real efficacy of these scaffolds (CMI), particularly regarding chondroprotection and the long-term onset of osteoarthritis.

Conditions

• Meniscal Degeneration
• Osteoarthritis of Knee
• Meniscus Injury

Interventions

Type	Name	Description
PROCEDURE	Arthroscopy & saline irrigation alone	the meniscus scaffold is aimed at replacing partial meniscus defect with a synthetic device.

Timeline

• Start date: 2020-11-29
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy