High-Purity Type I Collagen Augmentation in Meniscal Repair

March 29, 2026 updated by: Adichunchanagiri Institute of Medical Sciences, B G Nagara

Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mandya, Karnataka, India, 571448
        • Adichunchanagiri Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of High-Purity Type I Collagen Augmentation
Time Frame: From surgery to 2 months post-operatively
Incidence of device-related adverse events, including infection, inflammatory reactions, synovitis, or need for re-operationfollowing collagen-augmented meniscal repair.
From surgery to 2 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction Using Visual Analog Scale (VAS)
Time Frame: Baseline, 6 weeks, and 8 weeks
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.
Baseline, 6 weeks, and 8 weeks
Functional Outcome Using IKDC Subjective Knee Score
Time Frame: Baseline and 2 months
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.
Baseline and 2 months
Functional Outcome Using Lysholm Knee Score
Time Frame: Baseline and 2 months
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.
Baseline and 2 months
Early Meniscal Healing on MRI
Time Frame: 2 months post-operatively
MRI-based assessment of meniscal integrity, signal intensity at the repair site, and presence of fluid clefts or displacement. Participants with non-interpretable or unavailable MRI were categorized as 'Not assessable'.
2 months post-operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Clinical Knee Examination Findings - Range of Motion
Time Frame: Baseline, 6 weeks, and 8 weeks
Objective clinical examination findings were assessed during postoperative follow-up to evaluate knee recovery after collagen-augmented meniscal repair. Examination included knee range of motion (ROM) measured using a goniometer.
Baseline, 6 weeks, and 8 weeks
Objective Clinical Knee Examination Findings - Joint Line Tenderness
Time Frame: Baseline, 6 weeks, and 8 weeks
Objective clinical examination findings were assessed during postoperative follow-up to evaluate knee recovery after collagen-augmented meniscal repair. Examination included presence of Joint Line Tenderness at the time of examination.
Baseline, 6 weeks, and 8 weeks
Objective Clinical Knee Examination Findings - Knee Effusion
Time Frame: Baseline, 6 weeks, and 8 weeks
Objective clinical examination findings were assessed during postoperative follow-up to evaluate knee recovery after collagen-augmented meniscal repair. Examination included presence of Knee Effusion at the time of examination.
Baseline, 6 weeks, and 8 weeks
Objective Clinical Knee Examination Findings - McMurray Test
Time Frame: Baseline, 6 weeks, and 8 weeks

Objective clinical examination findings were assessed during postoperative follow-up to evaluate knee recovery after collagen-augmented meniscal repair.

The McMurray test is a standardized clinical examination maneuver used to assess the presence of meniscal pathology in the knee joint. The test is performed with the patient in the supine position while the examiner flexes the knee and applies rotational stress to the tibia while extending the knee. A positive McMurray test is defined by the presence of a palpable or audible click, pain, or both along the joint line during the maneuver, suggesting a meniscal tear or residual meniscal pathology. Results were recorded as positive or negative, and the number of participants with a positive test was reported at each follow-up time point.
Baseline, 6 weeks, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Investigators

  • Study Chair: Prema Dhanraj, MS, MCh, Rajarajeshwari Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2026

Primary Completion (Actual)

March 5, 2026

Study Completion (Actual)

March 8, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS/IEC/299/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This feasibility study is exploratory in nature and not powered for hypothesis testing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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