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
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 |
---|---|
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
04038-032
Brazil
Sponsor information
Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
University/education
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 |
---|---|
mariolenza@yahoo.com.br | |
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 |