Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/01/2010
Date assigned
18/02/2010
Last edited
18/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes