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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Clinical Knee Examination Findings - Range of Motion | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prema Dhanraj, MS, MCh | Rajarajeshwari Medical College and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adichunchanagiri Institute of Medical Sciences | Mandya | Karnataka | 571448 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40747200 | Background | 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. | |
| 39649230 |
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This feasibility study is exploratory in nature and not powered for hypothesis testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | From surgery to 2 months post-operatively |
|
8 weeks from the time of surgery, including surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Naveen Narayan | Adichunchanagiri Institute of Medical Sciences | +91-9980023372 | naveen_uno1@yahoo.co.in |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2026 | Mar 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| C000631847 | Osteogenesis Imperfecta, Type IV |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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|
| 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. | 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. | Baseline and 2 months |
| 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'. | 2 months post-operatively |
| Objective Clinical Knee Examination Findings - Joint Line Tenderness |
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 | 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 | 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 |
| 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. |
| 23318609 | Background | 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. |
| 21820843 | Background | 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. |
| 20448186 | Background | 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. |
| 24817049 | Background | 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. |
| 1516315 | Background | 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. |
| 21282546 | Background | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Meniscus Tear Side | Count of Participants | Participants |
|
| Tear Zone | Count of Participants | Participants |
|
| Longitudinal/Bucket-handle tears | Count of Participants | Participants |
|
| Time from Injury to Surgery (weeks) | Mean | Standard Deviation | weeks |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, and 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
|
|
|
| Secondary | 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'. | Posted | Count of Participants | Participants | 2 months post-operatively |
|
|
|
| Other Pre-specified | Objective Clinical Knee Examination Findings - Range of Motion | 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. | Posted | Mean | Standard Deviation | degrees | Baseline, 6 weeks, and 8 weeks |
|
|
|
| Other Pre-specified | Objective Clinical Knee Examination Findings - Joint Line Tenderness | 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. | Posted | Count of Participants | Participants | Baseline, 6 weeks, and 8 weeks |
|
|
|
| Other Pre-specified | Objective Clinical Knee Examination Findings - Knee Effusion | 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. | Posted | Count of Participants | Participants | Baseline, 6 weeks, and 8 weeks |
|
|
|
| Other Pre-specified | Objective Clinical Knee Examination Findings - McMurray Test | 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. | Posted | Count of Participants | Participants | Baseline, 6 weeks, and 8 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Device reaction | Product Issues | Non-systematic Assessment |
|
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| Not assessable / Indeterminate |
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