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

Completed

• Conditions: Humeral shaft fracture; Injury, Occupational Diseases, Poisoning; Fracture of shoulder and upper arm

• Registration Number: ISRCTN24835397
• Lead Sponsor: Federal University of Sao Paulo (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 126

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disability Arm Shoulder and Hand questionnare (DASH)<br>2. Time to return to previous activities<br><br>All outcomes will be assessed at 1, 2, 4, 8, 16, 24, 48, 96 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Pain on Visual Analogue Scale (VAS)<br>2. Radiologic assessment<br>3. Treatment cost<br>4. Rate of secondary surgery<br>5. Rate of complications<br>6. Social impact on 36-item short form health survey (SF-36)<br><br>All outcomes will be assessed at 1, 2, 4, 8, 16, 24, 48, 96 weeks.