Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

Recruiting

• Conditions: Humerus Shaft Fracture; Elderly (people Aged 65 or More)
• Interventions: Other: Patient Reported Outcome Measures; Other: Range of Motion

• Registration Number: NCT06605482
• Lead Sponsor: Fraser Orthopaedic Research Society

Brief Summary

The study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.

Detailed Description

A prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. Follow up will continue until 1 year post treatment to see functional and psychological outcomes.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-20
• Study Start: 2024-11-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis)
2. Ambulatory (with or without the use of walking aides)

Exclusion Criteria

1. Fractures with intra-articular extension
2. Ipsilateral upper extremity injury
3. Patients with vascular injury
4. Brachial plexus injury
5. Compartment syndrome
6. Pathological fractures
7. Open fractures
8. Periprosthetic fracture
9. BMI >40
10. Dementia or cognitive impairment that inhibits the collection of outcome measures
11. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
12. Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operative	Patient Reported Outcome Measures	Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing.
Operative	Range of Motion	Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing.
Non-operative	Patient Reported Outcome Measures	Humeral shaft fracture is conservatively managed with bracing or splinting
Non-operative	Range of Motion	Humeral shaft fracture is conservatively managed with bracing or splinting

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Score	Enrolment to 12 months post treatment	Patient reported outcome measure for shoulder and elbow function. The score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.

Secondary Outcome Measures

Name	Time	Method
12-Item Short Form Survey	Enrolment to 12 months post treatment	General health patient reported outcome measure. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Range of Motion	3 months post treatment	range of motion of shoulder and elbow

Trial Locations

Locations (1)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada