Health Condition 1: S431- Subluxation and dislocation of acromioclavicular joint
Conditions
Interventions
Intervention1: AC joint implants: This is a one time intervention. Patients will be implanted AC joint implants at the time of surgery and then will be followed up for improvement in medical condition
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed acromioclavicular joint ligament tear and who is planned for acromioclavicular joint repair through arthroscopy surgery.
Exclusion criteria
Exclusion criteria: 1. Subjects 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. Subject with inadequate tissue coverage of the operative site. 3. Subjects who are incarcerated or have pending incarceration. 4. Subjects with mental disorders. 5.Female participant who is pregnant or planning pregnancy during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in patient reported outcomes ASES, WOSI and VAS as well as radiological evaluation of effected joint repairTimepoint: 6 week 3 month 6 month 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording and analysis of complications including AE/SAEsTimepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed