Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/02/2012
Date assigned
12/03/2012
Last edited
01/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.unifesp.br/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes