Health Condition 1: S833- Tear of articular cartilage of knee, current
Conditions
Interventions
Intervention1: Knee Arthroscope: Patients will be followed up till 12 months after the surgery.
Control Intervention1: NIL: NIL
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject is willing and able to give Written informed consent for participation in the study. No history of surgery on affected knee Male or Female, aged between 18 to 75 years and skeletally mature patient. Subject scheduled for Knee arthroscopic surgery for fixation of Knee related ligaments and tendons
Exclusion criteria
Exclusion criteria: Subjects with a disease entity or condition that could hindered healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc. In case, subject has inadequate tissue coverage of the operative sight. Subjects with substance abuse/alcohol issues. Subjects who are incarcerated or have pending incarceration. Subjects with mental disorders Female participant who is pregnant or planning pregnancy during the course of the study. Subject who has contraindication mentioned in the IFU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiologic Evaluation by X-ray radiographs to observe the healing of tendon and ligaent repair after knee arthroscopy Evaluation of functional performance from baseline to last follow up by recording the Knee Injury and Osteoarthritis Outcome scoreTimepoint: Follow up time points - 1, 3, 6 and 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Follow-up of the patient recovery by analysing visual analogue score (VAS score) for pain assessment Evaluation of Safety of Device by record of any adverse event, serious adverse event and complication during follow up, especially the one mentioned in the Instruction of Use. (IFU)Timepoint: At 1, 3, and 6 months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt Ltd
Outcome results
None listed