Health Condition 1: S835- Sprain of cruciate ligament of knee
Conditions
Interventions
Intervention1: ACL reconstruction implants: Study participants will be followed at 6 week 3 month 6 month and 12 month
Control Intervention1: None: NA
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed ACL injury and who are planned for ACL repair through arthroscopy surgery.
Exclusion criteria
Exclusion criteria: 1 Patients with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc. 2 Patient has inadequate tissue coverage of the operative site. 3 Patients with concomitant meniscus or soft tissue injury. 4 Patient with history of effected ACL surgery 5 Patients with known history of metal allergies 6 Patients with documented mental disorders 7 Patients with life-threatning conditions 8 Patients who are incarcerated or have pending incarceration. 9 Associated other fractures which may interfere the rehabilitation and timely surgical fixation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1 Visual analogue scale (VAS) score will be recorded at pre-operative visit and post-operative follow up visits for assessment of improvement in pain 2 Assessment of safety of the ACL repair system will be assessed by analysing complications and serious/adverse events recorded at post-operative follow up visitsTimepoint: 6 week 3 month 6 month 12 month | — |
Primary
| Measure | Time frame |
|---|---|
| Performance of Auxilock ACL Repair System will be assessed by improvement in KOOS score from pre-operative to post-operative follow-up visitsTimepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed