Tibial open fractures fixation: intramedullary nailing versus bridge plating
Completed
- Conditions
- Tibial open fractureInjury, Occupational Diseases, PoisoningFracture of tibia
- Registration Number
- ISRCTN12166335
- Lead Sponsor
- Federal University of Sao Paulo (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Patients of both sexes
2. Adults who have growth plate closed to radiographic examination
3. Open fractures of the tibial shaft with less than 8 hours of occurrence
The classification used in this study for the degree of exposure of the fracture is described by Gustilo and Anderson in 1976 and modified by Gustilo, Mendoza and Williams in 1984, and will be included fractures of type I, II and IIIA.
Exclusion Criteria
1. Presence of previous traumatic or infectious lesion in the fractured tibia
2. Associated lesions which makes impossible the execution of a method or evaluation and postoperative rehabilitation
3. Chronic disease or other physical or mental conditions that preclude monitoring
4. Refusal to consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed of reoperation on months 3, 6, 9, or 12.
- Secondary Outcome Measures
Name Time Method 1. Non-union rate on months 6, 9 or 12<br>2. Infection rate<br>3. Mal-alignment rate on months 3, 6, 9 or 12<br>4. Functional score (Johner and Whrus) and life quality score (SF-36) on months 6 and 12