NCT07352410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2026

Completed
1 month until next milestone

Results Posted

Study results publicly available

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 12, 2026

Results QC Date

March 10, 2026

Last Update Submit

March 29, 2026

Conditions

Knee Meniscus InjuryMeniscal RepairMeniscus TearKnee Arthroscopy (for Diagnostic or Therapy)

Keywords

Meniscal TearMeniscus InjuriesKnee InjuriesArthroscopic Meniscal RepairMeniscus PreservationBiologic AugmentationCollagen ScaffoldType I CollagenCartilage RepairTissue Engineering

Outcome Measures

Primary Outcomes (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.

    From surgery to 2 months post-operatively

Secondary Outcomes (4)

  • Pain Reduction Using Visual Analog Scale (VAS)

    Baseline, 6 weeks, and 8 weeks

  • Functional Outcome Using IKDC Subjective Knee Score

    Baseline and 2 months

  • Functional Outcome Using Lysholm Knee Score

    Baseline and 2 months

  • Early Meniscal Healing on MRI

    2 months post-operatively

Other Outcomes (4)

  • Objective Clinical Knee Examination Findings - Range of Motion

    Baseline, 6 weeks, and 8 weeks

  • Objective Clinical Knee Examination Findings - Joint Line Tenderness

    Baseline, 6 weeks, and 8 weeks

  • Objective Clinical Knee Examination Findings - Knee Effusion

    Baseline, 6 weeks, and 8 weeks

  • +1 more other outcomes

Study Arms (1)

High-Purity Type I Collagen-Augmented Meniscal Repair

EXPERIMENTAL

Participants undergo standard arthroscopic meniscal repair augmented with High-Purity Type I Collagen applied at the repair site.

Device: High-Purity Type I Collagen

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.

High-Purity Type I Collagen-Augmented Meniscal Repair

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Related Publications (8)

  • 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.

    PMID: 40747200BACKGROUND

  • 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.

    PMID: 39649230BACKGROUND

  • 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.

    PMID: 23318609BACKGROUND

  • 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.

    PMID: 21820843BACKGROUND

  • 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.

    PMID: 20448186BACKGROUND

  • 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.

    PMID: 24817049BACKGROUND

  • 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.

    PMID: 1516315BACKGROUND

  • 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.

    PMID: 21282546BACKGROUND

MeSH Terms

Conditions

Knee InjuriesOsteogenesis Imperfecta, Type IV

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Results Point of Contact

Title
Prof Naveen Narayan
Organization
Adichunchanagiri Institute of Medical Sciences
naveen_uno1@yahoo.co.in
+91-9980023372

Study Officials

  • Prema Dhanraj, MS, MCh

    Rajarajeshwari Medical College and Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 20, 2026

Study Start

January 3, 2026

Primary Completion

March 5, 2026

Study Completion

March 8, 2026

Last Updated

April 8, 2026

Results First Posted

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

IN(1)