Recruiting

Observational Study

Sponsor:

Fraser Orthopaedic Research Society

Code:

NCT06605482

Conditions

Humerus Shaft Fracture

Elderly (People Aged 65 or More)

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Patient Reported Outcome Measures

Range of Motion

Study Details

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.

Conditions

Humerus Shaft Fracture

Elderly (People Aged 65 or More)

Study ID

NCT06605482

Start date

Nov 7, 2024

Status verified date

Feb, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

94 participants

Anticipated

Interventions and Outcome Measures

Arms

Operative

Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing.

Non-operative

Humeral shaft fracture is conservatively managed with bracing or splinting

Interventions

Patient Reported Outcome Measures

Participants will complete the following outcome measures American Shoulder and Elbow Surgeons Evaluation Questionnaire - upper limb function score 12-Item Short Form Survey - general health questionnaire

Range of Motion

Shoulder and Elbow Range of Motion collected at the time of radiographic union

Primary outcome measure

  • American Shoulder and Elbow Score [ Time Frame: Enrolment to 12 months post treatment ]

Central Contacts and Locations

Central contacts

Kyrsten Butterfield, BSc

604-553-3247kyrsten.butterfield@fraserhealth.ca

Bertrand Perey, MD

604-553-3247bperey@shaw.ca

Locations

Royal Columbian Hospital

Recruiting

New Westminster, British Columbia, Canada, V3L 3W7

Contacts

Kyrsten D Butterfield, BSc

6045533247kyrsten.butterfield@fraserhealth.ca

Manuja M Annthakumar, BSc

6045533247manuja.annthakumar@fraserhealth.ca

Principal Investigator:

Bertrand Perey, MD

More Information

Sponsor

Fraser Orthopaedic Research Society

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Keywords

  • patient outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fraser Orthopaedic Research Society on 2025-02-28.