Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study
Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
India
Adichunchanagiri Institute of Medical Sciences
Mandya
Time Frame
Start Date: 2026-01-03
Completion Date: 2026-03-08
Participants
Target number of participants: 18
Treatments
Experimental: High-Purity Type I Collagen-Augmented Meniscal Repair
Participants undergo standard arthroscopic meniscal repair augmented with High-Purity Type I Collagen applied at the repair site.
Related Therapeutic Areas
Sponsors
Leads: Adichunchanagiri Institute of Medical Sciences, B G Nagara