Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure
Conditions
Interventions
Intervention1: Sundesmosis system: Study participants will be followed at 6 week 3 month 6 month and 12 month
Control Intervention1: None: N.A.
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with confirmed diagnosis (MRI) of tibiofibular syndesmotic injury with or without associated ankle fractures.
Exclusion criteria
Exclusion criteria: 1. Infection (local or Systemic) Acute or Chronic Inflammation to the operative site. 2. Uncontrolled Seizure disorder/ Epilepsy. 3. Patients with known history of metal allergies. 4. Psychiatric patient. 5. Patients with life-threatening conditions. 6. Associated other fractures which may interfere the rehabilitation and timely surgical fixation. 7. Pregnant women or women planning pregnancy during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in patient reported outcomes. 2. Occurrence of complications including AEs/SAEs.Timepoint: 6 week 3 month 6 month 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken to return to pre-injury level of activities. 2. Patient satisfaction score. Timepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed