NCT07352410

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Meniscus Tear
• Knee Meniscus Injury
• Meniscal Repair
• Knee Arthroscopy (for Diagnostic or Therapy)

Interventions

Type	Name	Description
DEVICE	High-Purity Type I Collagen	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.

Timeline

• Start date: 2026-01-03
• Primary completion: 2026-03-05
• Completion: 2026-03-08
• First posted: 2026-01-20
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

1 site across 1 country: India