Trial Outcomes & Findings for High-Purity Type I Collagen Augmentation in Meniscal Repair (NCT NCT07352410)

Race and Ethnicity were not collected from any participant.

Incidence of device-related adverse events, including infection, inflammatory reactions, synovitis, or need for re-operationfollowing collagen-augmented meniscal repair.

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.

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.

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.

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'.

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.

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.

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.

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.