Performance and safety evaluation of fibula plate system for fibula related fracture
Phase 4
- Conditions
- Health Condition 1: S824- Fracture of shaft of fibulaHealth Condition 2: S828- Other fractures of lower leg
- Registration Number
- CTRI/2023/03/051079
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method