Fracture;ElbowSTAND-UPNCT05135949
Strength After Elbow Fractures in the Elderly
An observational study of Fracture;Elbow, run by Fraser Orthopaedic Research Society at 1 site in Canada.
Trial summary
Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fracture;Elbow
- What is being tested?
- Patient Reported Outcomes and Strength Test
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2021to 1 Jul 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
- Older adult
Study population: Elderly patients for displaced olecranon fractures
Who may be able to join
- ≥65 years of age
- Mayo type II olecranon fracture
- Ambulatory (with or without the use of walking aides)
Who cannot join
- Additional injuries to the affected arm or contralateral arm
- Associated nerve injury
- 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.)
- Injury or previous deficit to the contralateral arm
- Currently enrolled in any other research study involving drugs or medical devices
- Open fractures
- 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 Butterfield, 604-553-3247, Kyrsten.Butterfield@fraserhealth.ca
Farhad Moola
About this study
Official title: Strength and Function After Non-operative Treatment of Displaced Olecranon Fractures in the Elderly: Implications of Standing UP From a Seat
Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.
Read the detailed description
Elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. Patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. Assessments include, range of motion, patient reported outcomes and a strength test.
- Conditions
- Fracture;Elbow
- Being tested
- Patient Reported Outcomes, Strength Test
- Keywords
- Operative, Non Operative
- Medical subject headings
- Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported OutcomesOther
Satisfaction, Disabilities of the Shoulder, Arm and Hand
Strength TestOther
Handheld dynamometer to measure tricep extension
| Study group | Role | What they receive |
|---|---|---|
| Operative | Internal fixation of the displaced olecranon fracture. Receives: Other: Patient Reported Outcomes; Other: Strength Test | |
| Non Operative | Conservative treatment as determined by the treating surgeon. Receives: Other: Patient Reported Outcomes; Other: Strength Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension Strength
Patients will push down on their distal forearm through a hand held dynamometer, to measure tricep extension strength
Measured: 12 Months
Secondary outcomes (4)
Arc of Motion
Elbow extension and elbow flexion measured with a goniometer
Measured: 12 months
Mayo Elbow Performance Index
An instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living. Higher scores indicate a better outcome.
Measured: 12 Months
Disabilities of the Arm, Shoulder, and Hand
A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.
Measured: 12 Months
Satisfaction Score
Soccer out of 10, higher the score the better the outcome
Measured: 6 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start22 Feb 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture;ElbowStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Orthopaedic Research Society
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Farhad Moola, PhD, Principal investigator, Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135949
- Sponsor's protocol ID
- 2020-147
- Acronym
- STAND-UP
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Function After Non-operative Treatment of Displaced Olecranon Fractures in the Elderly: Implications of Standing UP From a Seat
- ClinicalTrials.gov ID
- NCT05135949
- Acronym / sponsor ID
- STAND-UP / 2020-147
- Conditions
- Fracture;Elbow
- Keywords
- Operative, Non Operative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fraser Orthopaedic Research SocietyResearch network
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 26 Nov 2021 (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.
Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.
Detailed description
Elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. Patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. Assessments include, range of motion, patient reported outcomes and a strength test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Other: Patient Reported Outcomes, Other: Strength TestInternal fixation of the displaced olecranon fracture. |
| Non Operative | – | Other: Patient Reported Outcomes, Other: Strength TestConservative treatment as determined by the treating surgeon. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients for displaced olecranon fractures
Key inclusion criteria (3 listed)
- ≥65 years of age
- Mayo type II olecranon fracture
- Ambulatory (with or without the use of walking aides)
Key exclusion criteria (8 listed)
- Additional injuries to the affected arm or contralateral arm
- Associated nerve injury
- 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.)
- Injury or previous deficit to the contralateral arm
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 OutcomesSatisfaction, Disabilities of the Shoulder, Arm and Hand | Other | Non Operative, Operative |
| Strength TestHandheld dynamometer to measure tricep extension | Other | Non Operative, Operative |
Primary outcome
Extension Strength
Time frame: 12 Months
Patients will push down on their distal forearm through a hand held dynamometer, to measure tricep extension strength
4 secondary outcomes
Arc of Motion
Time frame: 12 months
Mayo Elbow Performance Index
Time frame: 12 Months
Disabilities of the Arm, Shoulder, and Hand
Time frame: 12 Months
Satisfaction Score
Time frame: 6 weeks, 6 months and 12 months
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Farhad Moola, PhD principal investigator
Orthopaedic Surgeon
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 Fracture;Elbow, 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 3 inclusion and 8 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 27 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?
Extension Strength (time frame: 12 Months). 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 27 Feb 2025.