Clavicle FractureNCT05867355
Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
An observational study of Clavicle Fracture, run by University of Calgary at 1 site in Canada.
Trial summary
This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- surgical fixation
- Type of treatment
- Surgery or procedure
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.
Who may be able to join
- Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
- Aged 18 years of age or older and skeletally mature.
- Enrolled within 21 (+3 days) of injury.
- Willing and able to complete consent and study participation.
Who cannot join
- Pathological fractures.
- Clavicle non-unions.
- Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
- Polytrauma patients with injuries projected to affect rehabilitation course.
- Active malignancy.
- Inability to provide consent or complete follow-up.
- Incarcerated patients.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 5A1
Prism Schneider, 403-944-4518, prism.schneider@albertahealthservices.ca
Jessica Duong, 403-220-3366, jduong@ucalgary.ca
About this study
Official title: A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.
Read the detailed description
Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial.
This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time.
All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.
- Conditions
- Clavicle Fracture
- Being tested
- surgical fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical fixationProcedure or surgery
compare implant removal rates between surgical fixation techniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine implant removal rates
To report implant removal rates in an appropriately powered prospective cohort study.
Measured: 4 years
Identify rationale for implant removal
To report rationale for implant removal in an appropriately powered prospective cohort study.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start22 Mar 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Winnipeg Regional Health Authority, Thunder Bay Regional Health Sciences Centre, Montreal General Hospital, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Prism Schneider, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867355
- Sponsor's protocol ID
- REB20-2049
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
- ClinicalTrials.gov ID
- NCT05867355
- Acronym / sponsor ID
- REB20-2049
- Conditions
- Clavicle Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Winnipeg Regional Health Authority, Thunder Bay Regional Health Sciences Centre, Montreal General Hospital, Queen Elizabeth II Health Sciences Centre
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 May 2023 (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.
This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.
Detailed description
Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial.
This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time.
All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.
Key inclusion criteria (4 listed)
- Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
- Aged 18 years of age or older and skeletally mature.
- Enrolled within 21 (+3 days) of injury.
- Willing and able to complete consent and study participation.
Key exclusion criteria (7 listed)
- Pathological fractures.
- Clavicle non-unions.
- Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
- Polytrauma patients with injuries projected to affect rehabilitation course.
- Active malignancy.
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 |
|---|---|---|
| surgical fixationcompare implant removal rates between surgical fixation techniques. | Procedure or surgery | – |
Primary outcome
Determine implant removal rates
Time frame: 4 years
To report implant removal rates in an appropriately powered prospective cohort study.
Identify rationale for implant removal
Time frame: 4 years
To report rationale for implant removal in an appropriately powered prospective cohort study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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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. This study is not recruiting at the moment.
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 Clavicle Fracture, run by University of Calgary 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine implant removal rates (time frame: 4 years). The study lists 2 primary outcomes in all. 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 22 May 2023.