Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/05/2010
Date assigned
16/06/2010
Last edited
09/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Fabio Teruo Matsunaga

ORCID ID

Contact details

Rua Borges Lagoa
783
5th floor
Sao Paulo
04038042
Brazil

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

http://www.unifesp.br

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

  1. 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.

Additional files

Editorial Notes