Health Condition 1: S824- Fracture of shaft of fibula Health Condition 2: S828- Other fractures of lower leg
Conditions
Interventions
Intervention1: Fibula Plate System: Fibula plate system is intended to be used for fibula bone fracture surgeries for bone fixation.
Total duration of follow up will be 12 months
Control Interventio
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. Male or Female, aged between 18-65 years, skeletally mature patient. Patient schedule for surgery after trauma using fibula plate implants.
Exclusion criteria
Exclusion criteria: Patient with a fracture line more than 9 cm from the tip of the fibula, associated tibial pilon fractures, associated talar fractures and pathological fractures. Patient with Mental Disorders as well as comprehensive legal support. Scoliosis. Lack of willingness to make a commitment to return for required follow up visits. Pregnant Female. Drug and/or alcohol abuse. Morbid obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of fusion by radio logical evaluation. Timepoint: At 12 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue score (VAS) for pain assessmentTimepoint: At baseline, at 1, 3, and 6 months | — |
Countries
India
Contacts
Public ContactMr Gaurav Luthra
Auxein Medical Pvt Ltd
Outcome results
None listed