Overview
This prospective, single-arm feasibility study evaluates the safety, procedural feasibility, and early clinical outcomes of High-Purity Type I Collagen used as an adjunct in arthroscopic meniscal repair. The study aims to generate preliminary clinical, functional, and imaging data to inform the design of a future randomized controlled trial.
Description
Meniscal preservation is critical for long-term knee joint health, yet healing failure remains a concern, particularly in avascular zones. High-Purity Type I Collagen serves as a bioactive scaffold promoting cellular migration and early tissue integration. This study assesses early safety signals, feasibility metrics, patient-reported outcomes, and MRI-based healing characteristics following collagen-augmented meniscal repair.
Eligibility
Inclusion Criteria:
- Age 18 to 55 years
- Symptomatic meniscal tear confirmed on MRI and indicated for arthroscopic repair
- Tear patterns amenable to repair
- Stable knee or concomitant ACL reconstruction permitted
- Ability to comply with rehabilitation and follow-up
- Written informed consent provided
Exclusion Criteria:
- Advanced knee osteoarthritis (Kellgren-Lawrence grade ≥3)
- Irreparable meniscal tears requiring meniscectomy
- Active joint infection or inflammatory arthritis
- Prior surgical repair of the index meniscus
- Known hypersensitivity to collagen products
- Systemic conditions impairing wound healing
