At a glance
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Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study
In Brief
A clinical study evaluating High-Purity Type I Collagen for Meniscus Tear and 3 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
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.