Health Condition 1: M236- Other spontaneous disruption of ligament(s) of knee
Conditions
Interventions
Intervention1: PEEK CF interference screws for ACL/PCL reconstruction: 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 or PCL injury who are planned for ACL or PCL resonstruction 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. Patients with inadequate tissue coverage of the operative site. 3. Patients with history of effected knee arthroscopy surgery at the same site. 4. Patients with history of metal allergies. 5. Patients with documented mental disorders. 6. Patients with life threatening conditions. 7. Patients who are incarcerated or have pending incarceration. 8. Patients with associated fractures which may interfere the rehabilitation and timely surgical fixation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of PEEK CF interference screws will be assessed by improvement in KOOS and IKDC score from preoperative to post operative follow up visitsTimepoint: 6 Week 3 Month 6 Month 12 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety of PEEK CF interference screws will be done by recording and analysis of complications and serious/adverse events at post operative visits.Timepoint: 6 Week 3 Month 6 Month 12 Month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed