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
Adichunchanagiri Institute of Medical Sciences, B G Nagara
15 participants
Jan 3, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
Standard arthroscopic meniscal repair performed using established techniques (inside-out, outside-in, or all-inside). High-Purity Type I Collagen mesh is trimmed and applied over or within the repair site and secured using sutures or fibrin sealant, according to intra-operative requirements.
Locations(1)
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NCT07352410