Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients

NCT ID: NCT06605482

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Humerus Shaft Fracture Elderly (People Aged 65 or More)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Operative

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

Range of Motion

Intervention Type OTHER

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

Patient Reported Outcome Measures

Intervention Type 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

Humeral shaft fracture is conservatively managed with bracing or splinting

Range of Motion

Intervention Type OTHER

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

Patient Reported Outcome Measures

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Range of Motion

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fraser Orthopaedic Research Society

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kyrsten Butterfield, BSc

Role: CONTACT

604-553-3247

Bertrand Perey, MD

Role: CONTACT

604-553-3247

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kyrsten D Butterfield, BSc

Role: primary

6045533247

Manuja M Annthakumar, BSc

Role: backup

6045533247

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024137

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non Randomized Humerusshaft Fracture
NCT00205972 COMPLETED PHASE4
Study on Outcomes of Proximal Humerus Fractures
NCT07060664 NOT_YET_RECRUITING NA
LPHP-Philos-PHN Conservative Treatment
NCT00205959 COMPLETED PHASE4