Fractures of the NeckMC-studienNCT01139528
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
A study testing Bouquet pinning of the 5th metacarpal bone in people with Fractures of the Neck, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures of the Neck
- What is being tested?
- Bouquet pinning of the 5th metacarpal bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to Oct 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone
Who cannot join
- Less than 30 degrees of volar angulation in the fracture
- rotational deformity
- pseudoclawing
- intra-articular involvement
- ad latus displacement more than one half of a bone width
- concomitant fractures or soft tissue damage
Show all 9Show fewer
- admittance more than 14 days after injury
- non-compliant patient (language, drugs, tourist)
- patient who refuses to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.
- Conditions
- Fractures of the Neck
- Being tested
- Bouquet pinning of the 5th metacarpal bone
- Keywords
- Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal 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.
Bouquet pinning of the 5th metacarpal boneProcedure or surgery
The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Active comparator | Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins Receives: Procedure: Bouquet pinning of the 5th metacarpal bone |
| Conservative treatment | No intervention | No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick-DASH
Validated hand function score
Measured: 6 weeks, 3 months, 1 year, 2 years
Secondary outcomes (8)
Patient satisfaction
VAS scale
Measured: 6 weeks, 3 months, 1 year, 2 years
Pain
VAS scale
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Eq-5d
Validated quality of life score
Measured: 6 weeks, 3 months, 1 year, 2 years
Complications
All complications are noted
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Sick-leave
Days of sick-leave off work
Measured: 1 week, 6 weeks, 3 months (1 year, 2 years)
Range of motion in the joints in the 5th finger measured by hand therapist
total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
Measured: 3 months, 1 year, 2 years
Grip strength
Compared to the non-injured hand
Measured: 3 months, 1 year, 2 years
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
Measured: 6 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionOct 2013
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 Fractures of the NeckStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Asker & Baerum Hospital
- Responsible party
- Principal investigator, Ida Neergård Sletten, Oslo University Hospital
- Investigators
- Lars Nordsletten, Prof. MD, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139528
- Sponsor's protocol ID
- FASUUS 1529
- Acronym
- MC-studien
- Status last verified
- Apr 2015
- First submitted
- 18 May 2010
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.
PubMed 23060463
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01139528
- Acronym / sponsor ID
- MC-studien / FASUUS 1529
- Conditions
- Fractures of the Neck
- Keywords
- Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Asker & Baerum Hospital
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Jun 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.
A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Active comparator | Procedure: Bouquet pinning of the 5th metacarpal boneClosed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins |
| Conservative treatment | No intervention | –No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone
Key exclusion criteria (9 listed)
- Less than 30 degrees of volar angulation in the fracture
- rotational deformity
- pseudoclawing
- intra-articular involvement
- ad latus displacement more than one half of a bone width
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 |
|---|---|---|
| Bouquet pinning of the 5th metacarpal boneThe fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position | Procedure or surgery | Operative treatment |
Primary outcome
Quick-DASH
Time frame: 6 weeks, 3 months, 1 year, 2 years
Validated hand function score
8 secondary outcomes
Patient satisfaction
Time frame: 6 weeks, 3 months, 1 year, 2 years
Pain
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Eq-5d
Time frame: 6 weeks, 3 months, 1 year, 2 years
Complications
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Sick-leave
Time frame: 1 week, 6 weeks, 3 months (1 year, 2 years)
Range of motion in the joints in the 5th finger measured by hand therapist
Time frame: 3 months, 1 year, 2 years
Grip strength
Time frame: 3 months, 1 year, 2 years
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
Time frame: 6 weeks, 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 24 Apr 2015.
- Derived from this study: PubMed 23060463Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.
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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.
Lars Nordsletten, Prof. MD, PhD study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bouquet pinning of the 5th metacarpal bone in people with Fractures of the Neck, run by Oslo University Hospital at 1 site in Norway.
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 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 24 Apr 2015. 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 Norway. 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?
Quick-DASH (time frame: 6 weeks, 3 months, 1 year, 2 years). 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 NCT01139528, 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 24 Apr 2015.