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Tibial open fractures fixation: intramedullary nailing versus bridge plating

Tibial open fractures fixation - intramedullary nailing versus bridge plating: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12166335
Enrollment
80
Registered
2012-03-12
Start date
2004-08-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial open fracture Injury, Occupational Diseases, Poisoning Fracture of tibia

Interventions

Patients will be randomized to: 1. The intramedullary nail group: Prophylactic antibiotics will be used at the emergency room, and the participants will be undergo the operation within eight hours af

Sponsors

Federal University of Sao Paulo (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Need of reoperation on months 3, 6, 9, or 12.

Secondary

MeasureTime frame
1. Non-union rate on months 6, 9 or 12 2. Infection rate 3. Mal-alignment rate on months 3, 6, 9 or 12 4. Functional score (Johner and Whrus) and life quality score (SF-36) on months 6 and 12

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026