High-Purity Type I Collagen Augmentation in Meniscal Repair

Adichunchanagiri Institute of Medical Sciences, B G Nagara18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

High-Purity Type I CollagenDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

Outcomes

Primary Outcomes

Safety of High-Purity Type I Collagen Augmentation

Incidence of device-related adverse events, including infection, inflammatory reactions, synovitis, or need for re-operationfollowing collagen-augmented meniscal repair.

Time frame: From surgery to 2 months post-operatively

Secondary Outcomes

Pain Reduction Using Visual Analog Scale (VAS)

Change in patient-reported knee pain measured using the Visual Analog Scale. Pain intensity was assessed using a 10-point Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less pain and better clinical status, while higher scores indicate greater pain severity and worse symptoms.

Time frame: Baseline, 6 weeks, and 8 weeks

Functional Outcome Using IKDC Subjective Knee Score

Change in knee function assessed using the International Knee Documentation Committee (IKDC) subjective knee score, a patient-reported outcome measure assessing symptoms, knee function, and ability to perform daily and sports activities. Scores range from 0 to 100, where 0 represents the worst possible knee function and 100 represents normal knee function without limitations. Higher scores indicate better knee function, and an increase in score represents clinical improvement.

Time frame: Baseline and 2 months

Functional Outcome Using Lysholm Knee Score

Knee stability and functional performance were evaluated using the Lysholm Knee Scoring Scale, a validated questionnaire assessing pain, instability, swelling, limp, locking, and stair climbing ability. The total score ranges from 0 to 100, where higher scores indicate better knee function and fewer symptoms. A score of 100 represents optimal knee function, while lower scores indicate increasing levels of impairment. Therefore, an increase in Lysholm score represents clinical improvement.

Time frame: Baseline and 2 months

Data from ClinicalTrials.gov

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