Tibial open fractures fixation: intramedullary nailing versus bridge plating
| ISRCTN | ISRCTN12166335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12166335 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/02/2012
- Registration date
- 12/03/2012
- Last edited
- 01/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Federal University of Sao Paulo
Alameda dos Tangarás, 223
Alpes da Cantareira
Mairiporã, Sao Paulo
07600-000
Brazil
| Phone | +55 (0) 11 9165 7410 |
|---|---|
| danbal61@hotmail.com |
Study information
| Study design | Randomized single-center clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Tibial open fractures fixation - intramedullary nailing versus bridge plating: a randomized clinical trial |
| Study objectives | Intramedullary nail and bridge plating have similar results, but the bridge plating method has a lower cost. |
| Ethics approval(s) | Universidade Federal de São Paulo - Hospital São Paulo Ethics Committee, 10/12/2004, ref: CEP 1179/04 UNIFESP |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/08/2004 |
| Completion date | 16/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 participants |
| Key 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. |
| Key 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 |
| Date of first enrolment | 20/08/2004 |
| Date of final enrolment | 16/09/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
07600-000
Brazil
Sponsor information
University/education
Department of Orthopaedics and Traumatology
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil
| Phone | +55 (0) 11 5571 6621 |
|---|---|
| danbal61@hotmail.com | |
| Website | http://www.unifesp.br/ |
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
