Humerus Shaft FractureNCT06605482
Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients
An observational study of Humerus Shaft Fracture and Elderly (People Aged 65 or More), run by Fraser Orthopaedic Research Society at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Humerus Shaft Fracture, Elderly (People Aged 65 or More)
- What is being tested?
- Patient Reported Outcome Measures and Range of Motion
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who present to the Royal Columbian Hospital or the investigators clinic with a diaphysial humeral shaft fracture.
Who may be able to join
- 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)
Who cannot join
- Fractures with intra-articular extension
- Ipsilateral upper extremity injury
- Patients with vascular injury
- Brachial plexus injury
- Compartment syndrome
- Pathological fractures
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Kyrsten D Butterfield, BSc, 6045533247, kyrsten.butterfield@fraserhealth.ca
Manuja M Annthakumar, BSc, 6045533247, manuja.annthakumar@fraserhealth.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Patient Reported Outcome Measures, Range of Motion
- Keywords
- patient outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome MeasuresOther
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 MotionOther
Shoulder and Elbow Range of Motion collected at the time of radiographic union
| Study group | Role | What they receive |
|---|---|---|
| Operative | Humeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing. Receives: Other: Patient Reported Outcome Measures; Other: Range of Motion | |
| Non-operative | Humeral shaft fracture is conservatively managed with bracing or splinting Receives: Other: Patient Reported Outcome Measures; Other: Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrolment to 12 months post treatment
Secondary outcomes (2)
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.
Measured: Enrolment to 12 months post treatment
Range of Motion
range of motion of shoulder and elbow
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start7 Nov 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus Shaft FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605482
- Sponsor's protocol ID
- 2024137
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06605482
- Acronym / sponsor ID
- 2024137
- Keywords
- patient outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Other: Patient Reported Outcome Measures, Other: Range of MotionHumeral shaft fracture is surgically managed with open reduction internal fixation or intramedullary nailing. |
| Non-operative | – | Other: Patient Reported Outcome Measures, Other: Range of MotionHumeral shaft fracture is conservatively managed with bracing or splinting |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who present to the Royal Columbian Hospital or the investigators clinic with a diaphysial humeral shaft fracture.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- Fractures with intra-articular extension
- Ipsilateral upper extremity injury
- Patients with vascular injury
- Brachial plexus injury
- Compartment syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcome MeasuresParticipants 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 | Non-operative, Operative |
| Range of MotionShoulder and Elbow Range of Motion collected at the time of radiographic union | Other | Non-operative, Operative |
Primary outcome
American Shoulder and Elbow Score
Time frame: Enrolment to 12 months post treatment
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.
2 secondary outcomes
12-Item Short Form Survey
Time frame: Enrolment to 12 months post treatment
Range of Motion
Time frame: 3 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humerus Shaft Fracture and Elderly (People Aged 65 or More), run by Fraser Orthopaedic Research Society at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyrsten Butterfield, BSc (604-553-3247, kyrsten.butterfield@fraserhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Score (time frame: Enrolment to 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.