Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Universidade Federal de Sao Paulo approved on the 5th February 2010 (ref: 1595/09)
Study design
Randomised controlled 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 the contact details below to request a patient information sheet
Condition
Humeral shaft fracture
Intervention
Bridging plate osteosynthesis versus treatment with functional brace. Total duration of follow-up: 2 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
15/07/2010
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
126
Participant 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
Recruitment start date
15/07/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Borges Lagoa
Sao Paulo
04038042
Brazil
Sponsor information
Organisation
Federal University of Sao Paulo (Brazil)
Sponsor details
Rua Borges Lagoa
783
5th floor
Sao Paulo
04038042
Brazil
rose.dot@epm.br
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Sao Paulo (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
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23924198
Publication citations
-
Protocol
Matsunaga FT, Tamaoki MJ, Matsumoto MH, dos Santos JB, Faloppa F, Belloti JC, Treatment of the humeral shaft fractures--minimally invasive osteosynthesis with bridge plate versus conservative treatment with functional brace: study protocol for a randomised controlled trial., Trials, 2013, 14, 246, doi: 10.1186/1745-6215-14-246.