Conservative versus surgical interventions for treatment of the humeral shaft fractures in adults

ISRCTN	ISRCTN24835397
DOI	https://doi.org/10.1186/ISRCTN24835397
Protocol serial number	N/A
Sponsor	Federal University of Sao Paulo (Brazil)
Funder	Hospital Sao Paulo (Brazil)

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

Mr Fabio Teruo Matsunaga
Scientific

Rua Borges Lagoa
783, 5th floor
Sao Paulo
04038042
Brazil

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2012

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Rua Borges Lagoa

Sao Paulo
04038042
Brazil

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	07/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes