Contact information
Type
Scientific
Primary contact
Mr Adelmo Rezende da Costa
ORCID ID
Contact details
Department of Orthopaedics and Traumatology
Universidade Federal de São Paulo
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil
+55 11 5571 6621
mariolenza@yahoo.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of midshaft clavicle fractures: plate fixation versus figure-of-eight bandage: Randomised controlled clinical trial
Acronym
Study hypothesis
There is no difference between surgical versus conservative interventions for treating midshaft clavicle fractures
Ethics approval
The Ethics Committee of The Universidade Federal de São Paulo/Hospital São Paulo approved on the 29th of August 2008 (ref: CEP 0891/08 UNIFESP)
Study design
Randomised active controlled parallel group 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 contact details below to request a patient information sheet.
Condition
Clavicle fractures
Intervention
Patients will be randomised to
1. The surgical group (plate fixation):
All participants will be undergo the operation within two weeks after the injury; prophylactic antibiotics will be used. Under a general anaesthetic, the patient will be positioned in a beach-chair semi-sitting position. The involved shoulder will be prepared and draped, and an oblique incision will be made over the fracture site. The fracture site will be identified, and the fracture will be reduced and fixed with an antero-inferior plate (3.5 mm reconstruction plate). A sling will be used for comfort for seven to ten days, and then a physiotherapist will instruct the patient.
2. Figure-of-eight bandage:
In the conservative group, the figure-of-eight bandage will be used for 6 weeks, and every week the participants will return to check and adjust the immobilisation. In this way, the dominant hand can remain free and simple activities will be allowed (writing, keyboarding and other). After 6 weeks, participants will be encouraged to discard the bandage, but load bearing will not be recommended before osseous consolidation (around ten weeks).
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 6 weeks and at 3, 6 and 12 months and all primary and secondary outcomes will be reported.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Disability of Arm Shoulder and Hand (DASH) questionnaire, assessed at 3, 6 and 12 months
Secondary outcome measures
1. Range of movement
2. VAS (visual analogue scale)
3. Cosmetic appearance, assessed at the end of the follow up period
4. Time to consolidation
5. Clavicular length or shortening and shift
6. Complications / failure of treatment, monitored throughout the follow up period
All outcomes will be assessed at 3, 6 and 12 months unless otherwise stated.
Overall trial start date
01/01/2008
Overall trial end date
01/01/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults age 18-60
2. Patients with completely displaced middle third clavicle fractures, amenable to plate fixation with a minimum of three screws in both fragments
Recruitment of participants will take place in emergency centres of two hospitals in Espirito Santo and Sao Paulo, Brazil.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 participants
Participant exclusion criteria
1. Open fractures
2. Age under 18 or over 60 years
3. Fracture in the proximal or distal clavicle
4. Fracture associated with nerve or tendon injuries
5. Multiple injuries
6. Additional fractures in the same or contra-lateral limb
7. Previous fracture of the injured clavicle
8. Abnormal function of the uninjured side
9. Inflammatory joint disease
10. Cerebrovascular disease or other severe medical illness
11. Inability to give informed consent or to complete questionnaires
Recruitment start date
01/01/2008
Recruitment end date
01/01/2012
Locations
Countries of recruitment
Brazil
Trial participating centre
Department of Orthopaedics and Traumatology,
São Paulo
04038-032
Brazil
Sponsor information
Organisation
Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
Sponsor details
c/o Adelmo Rezende da Costa
Department of Orthopaedics and Traumatology
Universidade Federal de São Paulo
Rua Borges Lagoa
783 - 5th Floor
Sao Paulo
04038-032
Brazil
+55 (0)11 5571 6621
mariolenza@yahoo.com.br
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universidade Federal de Sao Paulo (UNIFESP) (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