Tibia bone related fracture fixation study
- Conditions
- Health Condition 1: V00-Y99- External causes of morbidity
- Registration Number
- CTRI/2022/10/046936
- Lead Sponsor
- Kaulmed Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 years or above, skeletally mature patient.
3. Subject is willing and able to complete required study visits or assessments.
4. Subject diagnosed as per indications.
1. Subjects with a disease entity or condition that could hindered bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
2. In case in subject has inadequate tissue coverage of the operative site. (Open fracture, Gustilo type IIIC)
3. Subjects unwilling to sign the Informed Consent document.
4. Subjects who are incarcerated or have pending incarceration.
5. Female participant who is pregnant or planning pregnancy during the course of the study.
6. Fracture that are not amenable to intramedullary tibia nailing technique
7. Morbid obesity (BMI (Kg/m2)) > 35
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method