Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448, India
NCT Number: NCT07352410
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Mandya, Karnataka, 571448, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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'.
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.
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.
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.
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.
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Other
Safety and Early Clinical Performance of High-Purity Type I Collagen Augmentation in Arthroscopic Meniscal Repair: A Prospective Feasibility Study
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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.
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