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Meniscus TearNCT07352410

High-Purity Type I Collagen Augmentation in Meniscal Repair

A study testing High-Purity Type I Collagen in people with Meniscus Tear and Knee Meniscus Injury, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
High-Purity Type I Collagen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteIndia
Study dates
3 Jan 2026to 8 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

India1 site

  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
High-Purity Type I Collagen
Keywords
Meniscal Tear, Meniscus Injuries, Knee Injuries, Arthroscopic Meniscal Repair, Meniscus Preservation, Biologic Augmentation, Collagen Scaffold, Type I Collagen, Cartilage Repair, Tissue Engineering
Medical subject headings
Knee Injuries, Osteogenesis Imperfecta, Type IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07352410
Study groupRoleWhat they receive
High-Purity Type I Collagen-Augmented Meniscal RepairExperimentalParticipants undergo standard arthroscopic meniscal repair augmented with High-Purity Type I Collagen applied at the repair site.
Receives: Device: High-Purity Type I Collagen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From surgery to 2 months post-operatively

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 6 weeks, and 8 weeks

  2. 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.

    Measured: Baseline and 2 months

  3. 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.

    Measured: Baseline and 2 months

  4. Early Meniscal Healing on MRI

    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'.

    Measured: 2 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start3 Jan 2026
  3. Primary completion5 Mar 2026
  4. Study completion8 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07352410
Sponsor's protocol ID
AIMS/IEC/299/2026
Status last verified
Mar 2026
First submitted
12 Jan 2026
Last updated
8 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This feasibility study is exploratory in nature and not powered for hypothesis testing.

Publications

  • Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

    PubMed 40747200

  • Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.

    PubMed 39649230

  • Bosisio FM, Estevez S. "Tire-bouchon" for vintage colloid. Int J Surg Pathol. 2013 Feb;21(1):47. doi: 10.1177/1066896912470163. No abstract available.

    PubMed 23318609

  • Paxton ES, Stock MV, Brophy RH. Meniscal repair versus partial meniscectomy: a systematic review comparing reoperation rates and clinical outcomes. Arthroscopy. 2011 Sep;27(9):1275-88. doi: 10.1016/j.arthro.2011.03.088. Epub 2011 Aug 6.

    PubMed 21820843

  • Lee HK, Yang Y, Su Z, Hyeon C, Lee TS, Lee HW, Kweon DH, Shin YK, Yoon TY. Dynamic Ca2+-dependent stimulation of vesicle fusion by membrane-anchored synaptotagmin 1. Science. 2010 May 7;328(5979):760-3. doi: 10.1126/science.1187722.

    PubMed 20448186

  • Duca RC, Hardy E, Salquebre G, Appenzeller BM. Hair decontamination procedure prior to multi-class pesticide analysis. Drug Test Anal. 2014 Jun;6 Suppl 1:55-66. doi: 10.1002/dta.1649.

    PubMed 24817049

  • Yamamoto H, Okumura S, Morita S, Obata K, Furuya K. Surgical correction of foot deformities after stroke. Clin Orthop Relat Res. 1992 Sep;(282):213-8.

    PubMed 1516315

  • Cleeland CS, Wang XS, Shi Q, Mendoza TR, Wright SL, Berry MD, Malveaux D, Shah PK, Gning I, Hofstetter WL, Putnam JB Jr, Vaporciyan AA. Automated symptom alerts reduce postoperative symptom severity after cancer surgery: a randomized controlled clinical trial. J Clin Oncol. 2011 Mar 10;29(8):994-1000. doi: 10.1200/JCO.2010.29.8315. Epub 2011 Jan 31.

    PubMed 21282546

Questions about this trial

What is this clinical trial studying?

A study testing High-Purity Type I Collagen in people with Meniscus Tear and Knee Meniscus Injury, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of High-Purity Type I Collagen Augmentation (time frame: From surgery to 2 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07352410, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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