Knee Arthroscopy (for Diagnostic or Therapy), Knee Meniscus Injury, Meniscal Repair, Meniscus Tear
Conditions
Keywords
Meniscal Tear, Meniscus Injuries, Knee Injuries, Arthroscopic Meniscal Repair, Meniscus Preservation, Biologic Augmentation, Collagen Scaffold, Type I Collagen, Cartilage Repair, Tissue Engineering
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.
Detailed description
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.
Interventions
DEVICEHigh-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.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of High-Purity Type I Collagen Augmentation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction Using Visual Analog Scale (VAS) | 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. |
| Functional Outcome Using IKDC Subjective Knee Score | 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. |
| Functional Outcome Using Lysholm Knee Score | 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. |
| Early Meniscal Healing on MRI | 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'. |
Countries
India
Contacts
STUDY_CHAIRPrema Dhanraj, MS, MCh
Rajarajeshwari Medical College and Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 6.4 |
| Longitudinal/Bucket-handle tears | 13 Participants |
| Meniscus Tear Side Lateral Meniscus Tear | 8 Participants |
| Meniscus Tear Side Medial Meniscus Tear | 10 Participants |
| Region of Enrollment India | 18 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
| Tear Zone ed-White Zone Tears | 11 Participants |
| Tear Zone Red-Red Zone Tears | 7 Participants |
| Time from Injury to Surgery (weeks) | 3.4 weeks STANDARD_DEVIATION 1.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
None listed