Conservative versus surgical interventions for treatment of the humeral shaft fractures in adults
| ISRCTN | ISRCTN24835397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24835397 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/05/2010
- Registration date
- 16/06/2010
- Last edited
- 09/08/2013
- 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 Fabio Teruo Matsunaga
Scientific
Scientific
Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil
Study information
| Study design | Randomised controlled 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 the contact details below to request a patient information sheet |
| Scientific title | Surgical intervention with bridging plate osteosynthesis versus conservative treatment with functional brace for humeral shaft fractures in adult men and women for better functional results and quality of life: a randomised controlled trial |
| Study objectives | Surgical intervention with bridging plate osteosynthesis for humeral shaft fractures leads to better functional results with better quality of life and earlier return to previous activities compared to conservative treatment with functional brace. |
| Ethics approval(s) | Universidade Federal de Sao Paulo approved on the 5th February 2010 (ref: 1595/09) |
| Health condition(s) or problem(s) studied | Humeral shaft fracture |
| Intervention | Bridging plate osteosynthesis versus treatment with functional brace. Total duration of follow-up: 2 years. |
| Intervention type | Other |
| Primary outcome measure | 1. Disability Arm Shoulder and Hand questionnare (DASH) 2. Time to return to previous activities All outcomes will be assessed at 1, 2, 4, 8, 16, 24, 48, 96 weeks. |
| Secondary outcome measures | 1. Pain on Visual Analogue Scale (VAS) 2. Radiologic assessment 3. Treatment cost 4. Rate of secondary surgery 5. Rate of complications 6. Social impact on 36-item short form health survey (SF-36) All outcomes will be assessed at 1, 2, 4, 8, 16, 24, 48, 96 weeks. |
| Overall study start date | 15/07/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 126 |
| Key inclusion criteria | 1. Men or women greater than or equal to 18 years old 2. Deviated humeral shaft fracture 3. Trauma-surgery delay of less than 21 days 4. Consent form signed |
| Key exclusion criteria | 1. Pathological fractures 2. Open humeral fractures 3. Associated vascular injury 4. Associated nerve injury 5. Inability to comply with rehabilitation or form completion 6. Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.) 7. Any situation that contra-indicate any of the methods to be randomised |
| Date of first enrolment | 15/07/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Borges Lagoa
Sao Paulo
04038042
Brazil
04038042
Brazil
Sponsor information
Federal University of Sao Paulo (Brazil)
University/education
University/education
Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil
| rose.dot@epm.br | |
| Website | http://www.unifesp.br |
"ROR" |
https://ror.org/02k5swt12 |
Funders
Funder type
Hospital/treatment centre
Hospital Sao Paulo (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/08/2013 | Yes | No |
