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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
RECRUITINGSafety of High-Purity Type I Collagen Augmentation
Incidence of device-related adverse events, including infection, inflammatory reactions, synovitis, or need for re-operation.
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
Time frame: Baseline, 6 weeks, and 2 months
Functional Outcome Using IKDC Subjective Knee Score
Change in knee function assessed using the International Knee Documentation Committee (IKDC) subjective knee score.
Time frame: Baseline and 2 months
Functional Outcome Using Lysholm Knee Score
Assessment of knee stability and function using the Lysholm knee scoring system
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
Time frame: 2 months post-operatively
Objective Clinical Knee Examination Findings
Assessment of knee effusion, range of motion, joint line tenderness, and meniscal provocation tests
Time frame: Baseline, 6 weeks, and 2 months
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