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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24835397

Enrollment

126

Registered

2010-06-16

Start date

2010-07-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humeral shaft fracture Injury, Occupational Diseases, Poisoning Fracture of shoulder and upper arm

Interventions

Bridging plate osteosynthesis versus treatment with functional brace. Total duration of follow-up: 2 years.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026