Treatment of midshaft clavicle fractures: plate fixation versus figure-of-eight bandage.

ISRCTN	ISRCTN66495030
DOI	https://doi.org/10.1186/ISRCTN66495030
Secondary identifying numbers	N/A

Submission date: 28/01/2010
Registration date: 18/02/2010
Last edited: 18/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Adelmo Rezende da Costa
Scientific

Department of Orthopaedics and Traumatology
Universidade Federal de São Paulo
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil

Phone	+55 11 5571 6621
Email	mariolenza@yahoo.com.br

Study information

Study design	Randomised active controlled parallel group 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 contact details below to request a patient information sheet.
Scientific title	Treatment of midshaft clavicle fractures: plate fixation versus figure-of-eight bandage: Randomised controlled clinical trial
Study objectives	There is no difference between surgical versus conservative interventions for treating midshaft clavicle fractures
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2008
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	120 participants
Key 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.
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Brazil

Study participating centre

Department of Orthopaedics and Traumatology,

São Paulo
04038-032
Brazil

Sponsor information

Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
University/education

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

Phone	+55 (0)11 5571 6621
Email	mariolenza@yahoo.com.br
"ROR"	https://ror.org/00bkgf580

Funders

Funder type

University/education

Universidade Federal de Sao Paulo (UNIFESP) (Brazil)

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