Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

NCT06605482 | Recruiting

• 1 other identifier: 2024137
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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)

Keywords

patient outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 12-Item Short Form Survey

  Enrolment to 12 months post treatment

• Range of Motion

  3 months post treatment

Study Arms (2)

Operative

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

Other: Patient Reported Outcome Measures; Other: Range of Motion

Non-operative

Humeral shaft fracture is conservatively managed with bracing or splinting

Other: Patient Reported Outcome Measures; Other: Range of Motion

Interventions

Patient Reported Outcome Measures OTHER

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

Non-operative; Operative

Range of Motion OTHER

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

Non-operative; Operative

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Fractures with intra-articular extension
• Ipsilateral upper extremity injury
• Patients with vascular injury
• Brachial plexus injury
• Compartment syndrome
• Pathological fractures
• Open fractures
• Periprosthetic fracture
• BMI \>40
• Dementia or cognitive impairment that inhibits the collection of outcome measures
• 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.)
• Inability to provide informed consent

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

MeSH Terms

Interventions

Patient Reported Outcome Measures; Range of Motion, Articular

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kyrsten Butterfield, BSc

CONTACT

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

Bertrand Perey, MD

CONTACT

604-553-3247; bperey@shaw.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 20, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CA (1)