Skip to main content
OpenTrials
Completed

NCT Number: NCT07352410

High-Purity Type I Collagen Augmentation in Meniscal Repair

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Purity Type I Collagen

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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'.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.