Displaced Midshaft Fracture of the Collar BoneNCT01078480
Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone
A study testing Operation using a precontoured titanium plate and screws and Displaced midshaft fracture of the collar bone in people with Displaced Midshaft Fracture of the Collar Bone, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws. The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Displaced Midshaft Fracture of the Collar Bone
- What is being tested?
- Operation using a precontoured titanium plate and screws and Displaced midshaft fracture of the collar bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.
Who cannot join
- bilateral fracture
- imminent skin perforation
- open fracture
- associated neurovascular effect
- unstable fracture of neck of scapula "floating shoulder"
- fracture of coincidental upper extremity distal for the shoulder
Show all 14Show fewer
- pathologic fracture
- the patient states that there was a unilateral or bilateral shoulder problem before the fracture
- fracture realized more than 14 days after it arose
- circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
- circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
- medical contraindication against surgery or general anaesthesia
- former participation in the trial
- former fracture contra/ipsilateral at the age of 15 or older
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Orthopaedic Division, Randers Hospital
Randers, Central Jutland, 8930
About this study
Official title: Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.
The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).
- Being tested
- Operation using a precontoured titanium plate and screws, Displaced midshaft fracture of the collar bone
- Keywords
- Fracture, Collar bone
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation using a precontoured titanium plate and screwsProcedure or surgery
Also called No other names.
Operation using a precontoured titanium plate and screws
Displaced midshaft fracture of the collar boneProcedure or surgery
Also called No other names.
Displaced midshaft fracture of the collar bone treated with an arm sling
| Study group | Role | What they receive |
|---|---|---|
| Arm sling treatment | Experimental | Displaced midshaft fracture of the collar bone treated with an arm sling Receives: Procedure: Displaced midshaft fracture of the collar bone |
| Operation | Experimental | Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws. Receives: Procedure: Operation using a precontoured titanium plate and screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) Score
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
Measured: 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes (1)
Constant-Murley Score
Measured: 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Displaced Midshaft Fracture of the Collar BoneStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Central Jutland Regional Hospital, Vejle Hospital, Randers Regional Hospital, Swemac Orthopaedics ApS
- Responsible party
- Sponsor
- Investigators
- Carsten M Jensen, M.D.Sci., Principal investigator, Orthopaedic Division, Central Jutland, Randers Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078480
- Sponsor's protocol ID
- ON-001-CMJ
- Status last verified
- Jan 2016
- First submitted
- 27 Feb 2010
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Qvist AH, Vaesel MT, Jensen CM, Jakobsen T, Jensen SL. Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion. Clin Orthop Relat Res. 2021 Jan 1;479(1):129-138. doi: 10.1097/CORR.0000000000001411.
PubMed 32675585
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT01078480
- Acronym / sponsor ID
- ON-001-CMJ
- Keywords
- Fracture, Collar bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Central Jutland Regional Hospital, Vejle Hospital, Randers Regional Hospital, Swemac Orthopaedics ApS
- Study start
- Apr 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Mar 2010 (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 study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.
The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm sling treatment | Experimental | Procedure: Displaced midshaft fracture of the collar boneDisplaced midshaft fracture of the collar bone treated with an arm sling |
| Operation | Experimental | Procedure: Operation using a precontoured titanium plate and screwsDisplaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.
Key exclusion criteria (14 listed)
- bilateral fracture
- imminent skin perforation
- open fracture
- associated neurovascular effect
- unstable fracture of neck of scapula "floating shoulder"
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 |
|---|---|---|
| Operation using a precontoured titanium plate and screwsAlso: No other names.Operation using a precontoured titanium plate and screws | Procedure or surgery | Operation |
| Displaced midshaft fracture of the collar boneAlso: No other names.Displaced midshaft fracture of the collar bone treated with an arm sling | Procedure or surgery | Arm sling treatment |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 6 weeks, 3 months, 6 months, 1 year
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
1 secondary outcome
Constant-Murley Score
Time frame: 6 weeks, 3 months, 6 months, 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 22 Jan 2016.
- Derived from this study: PubMed 32675585Qvist AH, Vaesel MT, Jensen CM, Jakobsen T, Jensen SL. Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion. Clin Orthop Relat Res. 2021 Jan 1;479(1):129-138. doi: 10.1097/CORR.0000000000001411.
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.
Carsten M Jensen, M.D.Sci. principal investigator
Orthopaedic Division, Central Jutland, Randers Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation using a precontoured titanium plate and screws and Displaced midshaft fracture of the collar bone in people with Displaced Midshaft Fracture of the Collar Bone, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 inclusion and 14 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 22 Jan 2016. 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 Denmark. 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?
Disabilities of the Arm, Shoulder and Hand (DASH) Score (time frame: 6 weeks, 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01078480, which also lists 1 linked publication.
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 Jan 2016.