High-Purity Type I Collagen Augmentation in Meniscal Repair

Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study

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.

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.

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