Skip to content

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: A Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06605482
Enrollment
94
Registered
2024-09-20
Start date
2024-11-07
Completion date
2027-12-31
Last updated
2025-02-28

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

Conditions

Elderly (People Aged 65 or More), Humerus Shaft Fracture

Keywords

patient outcomes

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.

Interventions

OTHERPatient 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

OTHERRange of Motion

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

Sponsors

Fraser Orthopaedic Research Society
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
American Shoulder and Elbow ScoreEnrolment to 12 months post treatmentPatient 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

MeasureTime frameDescription
12-Item Short Form SurveyEnrolment to 12 months post treatmentGeneral health patient reported outcome measure. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Range of Motion3 months post treatmentrange of motion of shoulder and elbow

Countries

Canada

Contacts

Primary ContactKyrsten Butterfield, BSc
kyrsten.butterfield@fraserhealth.ca604-553-3247
Backup ContactBertrand Perey, MD
bperey@shaw.ca604-553-3247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026