High-Purity Type I Collagen Augmentation in Meniscal Repair

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Enrolling

Conditions: Knee Arthroscopy (for Diagnostic or Therapy); Meniscus Tear; Meniscal Repair; Knee Meniscus Injury

Treatments: Device: High-Purity Type I Collagen

Study type: Interventional

Funder types: Other

Identifiers

NCT07352410

AIMS/IEC/006/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

High-Purity Type I Collagen-Augmented Meniscal Repair

Experimental group

Description:

Participants undergo standard arthroscopic meniscal repair augmented with High-Purity Type I Collagen applied at the repair site.

Treatment:

Device: High-Purity Type I Collagen