An interventional study of High-Purity Type I Collagen in Meniscus Tear, Knee Meniscus Injury and Meniscal Repair, sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
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.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: From surgery to 2 months post-operatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 2 months post-operatively
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.
Time frame: Baseline, 6 weeks, and 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks, and 8 weeks
| Milestone | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
Incidence of device-related adverse events, including infection, inflammatory reactions, synovitis, or need for re-operationfollowing collagen-augmented meniscal repair.
| Participants | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Device-related adverse events | 0 |
| Infections | 0 |
| Synovitis | 0 |
| Reoperation | 0 |
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.
| score on a scale | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 62 ± 1.1 |
| 6 weeks | 3.9 ± 1.2 |
| 8 weeks | 3.1 ± 1.0 |
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.
| score on a scale | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 58.1 ± 9.4 |
| 2 months | 67.5 ± 10.1 |
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.
| score on a scale | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 62.4 ± 8.7 |
| 2 months | 74.8 ± 9.1 |
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'.
| Participants | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Complete healing | 7 |
| Partial healing | 6 |
| Incomplete healing | 3 |
| Not assessable / Indeterminate | 2 |
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.
| degrees | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 102 ± 12 |
| 6 weeks | 118 ± 10 |
| 8 weeks | 128 ± 8 |
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.
| Participants | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 18 |
| 6 weeks | 6 |
| 8 weeks | 2 |
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.
| Participants | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 12 |
| 6 weeks | 4 |
| 8 weeks | 1 |
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.
| Participants | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Baseline | 15 |
| 6 weeks | 5 |
| 8 weeks | 2 |
Collected over 8 weeks from the time of surgery, including surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-Purity Type I Collagen-Augmented Meniscal Repair | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Event | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| ReoperationSurgical and medical procedures | 0/18 |
| Event | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Surgical Site InfectionInfections and infestations | 0/18 |
| SynovitisMusculoskeletal and connective tissue disorders | 0/18 |
| Device reactionProduct Issues | 0/18 |
| Age, Continuous(years) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Mean | 29.6 ± 6.4 |
| Sex: Female, Male(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Female | 7 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|
| Region of Enrollment(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| India | 18 |
| Meniscus Tear Side(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Medial Meniscus Tear | 10 |
| Lateral Meniscus Tear | 8 |
| Tear Zone(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Red-Red Zone Tears | 7 |
| ed-White Zone Tears | 11 |
| Longitudinal/Bucket-handle tears(Participants) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Count of participants | 13 |
| Time from Injury to Surgery (weeks)(weeks) | High-Purity Type I Collagen-Augmented Meniscal Repair |
|---|---|
| Mean | 3.4 ± 1.2 |
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Plan to share: No — This feasibility study is exploratory in nature and not powered for hypothesis testing.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara