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

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.

Study Overview

• Status: Recruiting
• Conditions: Humerus Shaft Fracture; Elderly (people Aged 65 or More)
• Intervention / Treatment: Other: Patient Reported Outcome Measures; Other: Range of Motion

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 Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Kyrsten Butterfield, BSc; Phone Number: 604-553-3247; Email: kyrsten.butterfield@fraserhealth.ca
• Study Contact Backup: Name: Bertrand Perey, MD; Phone Number: 604-553-3247; Email: bperey@shaw.ca

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Recruiting
      • Royal Columbian Hospital
      • Contact: Kyrsten D Butterfield, BSc; Phone Number: 6045533247; Email: kyrsten.butterfield@fraserhealth.ca
      • Contact: Manuja M Annthakumar, BSc; Phone Number: 6045533247; Email: manuja.annthakumar@fraserhealth.ca
      • Contact: Bertrand Perey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who present to the Royal Columbian Hospital or the investigators clinic with a diaphysial humeral shaft fracture.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operative; Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing.	Other: 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; Other: Range of Motion; Shoulder and Elbow Range of Motion collected at the time of radiographic union
Non-operative; Humeral shaft fracture is conservatively managed with bracing or splinting	Other: 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; Other: Range of Motion; Shoulder and Elbow Range of Motion collected at the time of radiographic union

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Score	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.	Enrolment to 12 months post treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fraser Orthopaedic Research Society

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: patient outcomes
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2024137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No