Clavicle FractureNCT00872105
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
A study testing Non-operative Treatment and Operative Treatment in people with Clavicle Fracture and Fractures, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Clavicle Fracture, Fractures
- What is being tested?
- Non-operative Treatment and Operative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Sep 2019
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Men or women aged 16 to 60 years of age
- Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
- Fractures within 28 days post injury
- Provision of informed consent
Who cannot join
- Pathological fractures
- Non-displaced (cortical contact) distal clavicle fractures
- Open clavicle fractures
- Presence of vascular injury
- Fractures more than 28 days post-injury
- Limited life expectancy due to significant medical co-morbidity
Show all 9Show fewer
- Medical contraindication to surgery
- Inability to comply with rehabilitation or form completion
- Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
- Conditions
- Clavicle Fracture, Fractures
- Being tested
- Non-operative Treatment, Operative Treatment
- Keywords
- clavicle, fractures, distal
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-operative TreatmentProcedure or surgery
Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon.
Operative TreatmentProcedure or surgery
The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows:
Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft)
| Study group | Role | What they receive |
|---|---|---|
| Non-operative treatment | Other | The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture. Receives: Procedure: Non-operative Treatment |
| Operative treatment | Active comparator | The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws. Receives: Procedure: Operative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
Measured: 2 years
Secondary outcomes (1)
The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2018
- Study completionSep 2019
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 Unity Health TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Fraser Health, University of British Columbia, London Health Sciences Centre, University of Calgary, Nova Scotia Health Authority, Winnipeg Regional Health Authority, McGill University Health Centre/Research Institute of the McGill University Health Centre, The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Jeremy A Hall, MD, FRCS(C), Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872105
- Sponsor's protocol ID
- Distal Clavicle Study
- Status last verified
- Nov 2019
- First submitted
- 30 Mar 2009
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
- ClinicalTrials.gov ID
- NCT00872105
- Acronym / sponsor ID
- Distal Clavicle Study
- Conditions
- Clavicle Fracture, Fractures
- Keywords
- clavicle, fractures, distal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Fraser Health, University of British Columbia, London Health Sciences Centre, University of Calgary, Nova Scotia Health Authority, Winnipeg Regional Health Authority, McGill University Health Centre/Research Institute of the McGill University Health Centre, The Ottawa Hospital
- Study start
- Mar 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 31 Mar 2009 (estimated)
- 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 is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-operative treatment | Other | Procedure: Non-operative TreatmentThe first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture. |
| Operative treatment | Active comparator | Procedure: Operative TreatmentThe second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Men or women aged 16 to 60 years of age
- Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
- Fractures within 28 days post injury
- Provision of informed consent
Key exclusion criteria (9 listed)
- Pathological fractures
- Non-displaced (cortical contact) distal clavicle fractures
- Open clavicle fractures
- Presence of vascular injury
- Fractures more than 28 days post-injury
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 |
|---|---|---|
| Non-operative TreatmentStandard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon. | Procedure or surgery | Non-operative treatment |
| Operative TreatmentThe operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows: Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft) | Procedure or surgery | Operative treatment |
Primary outcome
The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
Time frame: 2 years
1 secondary outcome
The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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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.
Jeremy A Hall, MD, FRCS(C) principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-operative Treatment and Operative Treatment in people with Clavicle Fracture and Fractures, run by Unity Health Toronto 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 9 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: finished, as of the sponsor's last update on 27 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire. (time frame: 2 years). 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 Nov 2019.