Fifth Metacarpal Neck FractureCONFraMNCT00704002
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
A study testing antegrade intramedullary splinting and conservative treatment in people with Fifth Metacarpal Neck Fracture, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fifth Metacarpal Neck Fracture
- What is being tested?
- antegrade intramedullary splinting and conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Jun 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- displaced neck fracture of the fifth metacarpal (at least 30° angulation)
- isolated injury
- age between 18 and 75 years
- informed consent
Who cannot join
- rotational displacement
- open fracture
- injury older than one week
- treatment other than within this study
- other relevant injuries of the upper extremities
- other injury or disease of the hand
Show all 12Show fewer
- pregnancy
- missing informed consent
- incompliance
- coagulopathy
- allergy to metallic implants
- Patients who have participated in any other device or drug clinical trial within the previous month
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.
Read the detailed description
The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.
- Conditions
- Fifth Metacarpal Neck Fracture
- Being tested
- antegrade intramedullary splinting, conservative treatment
- Keywords
- neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antegrade intramedullary splintingProcedure or surgery
antegrade intramedullary splinting with 2 to 3 small K-wires
conservative treatmentProcedure or surgery
conservative treatment with 2-finger splint for one week
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | antegrade intramedullary splinting Receives: Procedure: antegrade intramedullary splinting |
| B | Active comparator | conservative treatment Receives: Procedure: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Measured: 3 months
Secondary outcomes (1)
pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionFeb 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fifth Metacarpal Neck FractureStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Schädel-Höpfner, MD, Principal investigator, Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704002
- Sponsor's protocol ID
- CONFraM
- Acronym
- CONFraM
- Status last verified
- Mar 2013
- First submitted
- 23 Jun 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
- ClinicalTrials.gov ID
- NCT00704002
- Acronym / sponsor ID
- CONFraM / CONFraM
- Conditions
- Fifth Metacarpal Neck Fracture
- Keywords
- neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Jun 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.
This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.
Detailed description
The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: antegrade intramedullary splintingantegrade intramedullary splinting |
| B | Active comparator | Procedure: conservative treatmentconservative treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- displaced neck fracture of the fifth metacarpal (at least 30° angulation)
- isolated injury
- age between 18 and 75 years
- informed consent
Key exclusion criteria (12 listed)
- rotational displacement
- open fracture
- injury older than one week
- treatment other than within this study
- other relevant injuries of the upper extremities
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 |
|---|---|---|
| antegrade intramedullary splintingantegrade intramedullary splinting with 2 to 3 small K-wires | Procedure or surgery | A |
| conservative treatmentconservative treatment with 2-finger splint for one week | Procedure or surgery | B |
Primary outcome
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 3 months
1 secondary outcome
pain
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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.
Michael Schädel-Höpfner, MD principal investigator
Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antegrade intramedullary splinting and conservative treatment in people with Fifth Metacarpal Neck Fracture, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 12 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: stopped early, as of the sponsor's last update on 29 Mar 2013. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
Disability of the Arm, Shoulder and Hand (DASH) questionnaire (time frame: 3 months). 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 29 Mar 2013.