Displaced, Midshaft Clavicular FracturesNCT00642265
The Treatment of Clavicular Fractures
A study testing osteosynthesis and sling in people with Displaced, Midshaft Clavicular Fractures, run by University Hospital, Ghent at 6 sites in Belgium.
Trial summary
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Displaced, Midshaft Clavicular Fractures
- What is being tested?
- osteosynthesis and sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesBelgium
- Study dates
- Apr 2008to 27 May 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 year
- 100% displaced midshaft clavicular fracture
- shortening
- male: 18mm
- female: 14mm
Who cannot join
- pregnancy
- pathological fracture
- open fracture
- history of frozen shoulder
- ipsilateral fracture of shoulder or scapula
- neurovascular injury
- contraindication to anaesthesia
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Stedelijk Ziekenhuis Aalst
Aalst, 9300
AZ Sint Jan-Brugge
Bruges, 8000
Jan Palfijnziekenhuis
Ghent, 9000
University Hospital Ghent
Ghent, 9000
Stedelijk Ziekenhuis Roeselare
Roeselare, 8800
Sint-Andries Ziekenhuis
Tielt, 8700
About this study
Official title: The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.
Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.
- Conditions
- Displaced, Midshaft Clavicular Fractures
- Being tested
- osteosynthesis, sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteosynthesisProcedure or surgery
operative treatment
slingOther
conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | operative treatment Receives: Procedure: osteosynthesis |
| 2 | Active comparator | conservative treatment Receives: Other: sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Union
Measured: 1 year
Functionality
Measured: 1 year
Secondary outcomes (6)
Complications
Measured: 1 year
Time to heal
Measured: 1 year
Cost
Measured: 1 year
Relation with medication
Measured: 1 year
Relation with smoking
Measured: 1 year
Relation with job
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2008
- Primary completion27 May 2009
- Study completion27 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Displaced, Midshaft Clavicular FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Responsible party
- Sponsor
- Investigators
- Lieven De Wilde, MD, PhD, Principal investigator, University Hospital, GhentBart Berghs, MD, Principal investigator, AZ Sint-Jan AVPieter-Jan Vandekerckhove, MD, Principal investigator, Sint-Andriesziekenhuis TieltJ. Van Den Daele, MD, Principal investigator, Stedelijk Ziekenhuis RoeselareJ. Vanonverschelde, MD, Principal investigator, Stedelijk Ziekenhuis AalstG. Vandendriessche, MD, Principal investigator, Jan Palfijnziekenhuis Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642265
- Sponsor's protocol ID
- 2007/573
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2008
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
- ClinicalTrials.gov ID
- NCT00642265
- Acronym / sponsor ID
- 2007/573
- Conditions
- Displaced, Midshaft Clavicular Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Study start
- Apr 2008 (actual)
- Primary completion
- 27 May 2009 (actual)
- Study completion
- 27 May 2009 (actual)
- First posted
- 25 Mar 2008 (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.
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.
Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: osteosynthesisoperative treatment |
| 2 | Active comparator | Other: slingconservative treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 year
- 100% displaced midshaft clavicular fracture
- shortening
Key exclusion criteria (7 listed)
- pregnancy
- pathological fracture
- open fracture
- history of frozen shoulder
- ipsilateral fracture of shoulder or scapula
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 |
|---|---|---|
| osteosynthesisoperative treatment | Procedure or surgery | 1 |
| slingconservative treatment | Other | 2 |
Primary outcome
Union
Time frame: 1 year
Functionality
Time frame: 1 year
6 secondary outcomes
Complications
Time frame: 1 year
Time to heal
Time frame: 1 year
Cost
Time frame: 1 year
Relation with medication
Time frame: 1 year
Relation with smoking
Time frame: 1 year
Relation with job
Time frame: 1 year
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 4 Jan 2023.
- Related InfoLink provided by the sponsor.
Related trials for Displaced, Midshaft Clavicular Fractures
RecruitingObservational study
Risk Factors for Development of Non-union of Displaced Midshaft Clavicle Fractures
Non-union of Fractures
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.
Lieven De Wilde, MD, PhD principal investigator
University Hospital, Ghent
Bart Berghs, MD principal investigator
AZ Sint-Jan AV
Pieter-Jan Vandekerckhove, MD principal investigator
Sint-Andriesziekenhuis Tielt
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteosynthesis and sling in people with Displaced, Midshaft Clavicular Fractures, run by University Hospital, Ghent at 6 sites in Belgium.
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 5 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: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
Union (time frame: 1 year). 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 4 Jan 2023.