Plain English Summary
Background and study aims
Open fractures of the tibia (shinbone) are very frequent and severe. The aim of this study is to compare two different operations, intramedullary nailing and bridge plating, for the treatment of open fractures of the tibia.
Who can participate?
Patients who suffer open fractures of the tibia.
What does the study involve?
Patients will be randomly allocated to undergo either the intramedullary nailing or the bridge plating operation.
What are the possible benefits and risks of participating?
By participating in the study the patient will benefit from thorough monitoring and unrestricted access to professionals involved in the study and it should be easy to treat possible complications that can occur. The risks to the patient are a result of the nature of this injury, in which the most common complications are infection and non-union (permanent failure of healing). Participation in the study adds no additional risk.
Where is the study run from?
The study will be performed at the Hospital São Paulo, Brazil.
When is the study starting and how long is it expected to run for?
The study started in August 2004 and was completed in September 2009.
Who is funding the study?
Universidade Federal de São Paulo (UNIFESP).
Who is the main contact?
Daniel Balbachevsky.
danbal61@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Daniel Balbachevsky
ORCID ID
Contact details
Federal University of Sao Paulo
Alameda dos Tangarás
223
Alpes da Cantareira
Mairiporã
Sao Paulo
07600-000
Brazil
+55 (0) 11 9165 7410
danbal61@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Tibial open fractures fixation - intramedullary nailing versus bridge plating: a randomized clinical trial
Acronym
Study hypothesis
Intramedullary nail and bridge plating have similar results, but the bridge plating method has a lower cost.
Ethics approval
Universidade Federal de São Paulo - Hospital São Paulo Ethics Committee, 10/12/2004, ref: CEP 1179/04 UNIFESP
Study design
Randomized single-center clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Tibial open fracture
Intervention
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 after the injury. Under a anesthetic procedure (local or general), the patient will be positioned in a supine position. The involved leg will be prepared and draped, and an irrigation procedure with saline solution and debridement of devitalized soft tissues will be done at the fracture site. The fracture site will be reduced and fixed with a non-reamed locked intramedullary nail. The soft tissues will be closed or will be left open if tense. A cast will be used for comfort for 7 days, and then a physiotherapist will instruct the patient.
2. The bridge plating group:
The same preparation of nail group, but the fracture will be fixed with a narrow 4,5 DC-plate, usually with 12 to 16 holes. Two or three bicortical screws will be used in each side
Identical care program for rehabilitation will be done in each of compared groups. Following enrolment in the study, all the participants will be seen every week during the first month and at 3, 6 and 12 months and all primary and secondary outcomes will be reported.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Need of reoperation on months 3, 6, 9, or 12.
Secondary outcome measures
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
Overall trial start date
20/08/2004
Overall trial end date
16/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 participants
Participant 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
Recruitment start date
20/08/2004
Recruitment end date
16/09/2009
Locations
Countries of recruitment
Brazil
Trial participating centre
Federal University of Sao Paulo
Mairiporã, Sao Paulo
07600-000
Brazil
Sponsor information
Organisation
Federal University of Sao Paulo (Brazil)
Sponsor details
Department of Orthopaedics and Traumatology
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil
+55 (0) 11 5571 6621
danbal61@hotmail.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Federal University of São Paulo (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list