N/A N=18 Treatment

High-Purity Type I Collagen Augmentation in Meniscal Repair

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

Bottom Line

View on ClinicalTrials.gov: NCT07352410 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Safety of High-Purity Type I Collagen Augmentation — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-Purity Type I Collagen (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Primary completion: Mar 2026

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of High-Purity Type I Collagen Augmentation	0; 0; 0; 0	—
SECONDARY Pain Reduction Using Visual Analog Scale (VAS)	62; 3.9; 3.1	—
SECONDARY Functional Outcome Using IKDC Subjective Knee Score	58.1; 67.5	—
SECONDARY Functional Outcome Using Lysholm Knee Score	62.4; 74.8	—
SECONDARY Early Meniscal Healing on MRI	7; 6; 3; 2	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07352410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.