Fracture of Metacarpal Bone1-2-KiWINCT01803789
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
A study testing Single Kirschner Wire and Double Kirschner Wire in people with Fracture of Metacarpal Bone, run by University Medicine Greifswald at 12 sites in Germany.
Trial summary
Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Metacarpal Bone
- What is being tested?
- Single Kirschner Wire and Double Kirschner Wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 12 sitesGermany
- Study dates
- May 2013to Jul 2017
- 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 ≥18 years with a metacarpal V neck fracture with a palmar angulation and/or shortening and /or rotational deformity as determined on radiological diagnosis
- Trauma within 10 days before appearing in the study centre
- No specific medical treatment before
- Ability to fully understand the character and implications of the clinical trial
- Written or oral (in case of an injury of the dominant hand, if so attested by witnesses)consent
Who cannot join
- Indications for conservative therapy
- Patient is not suitable for anaesthesia
- Other physical conditions or characteristics which made surgical interventions inappropriate or to risky (e.g. open fractures, polytrauma, pregnancy, acute infections, pathological fractures)
- Prior participation in this study (e.g. injury of the contralateral hand) or participation in other interventional studies with the same objective
- Physical or mental diseases which makes the consequent participation in diagnostic, therapy and the follow-up-examinations unlikely
- Lacking language skills
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Sana Clinical Centre Lichtenberg
Berlin, 10365
Vivantes Hospital Am Urban
Berlin, 10967
Trauma Hospital Berlin
Berlin, 12683
University Medicine Düsseldorf
Düsseldorf, 40225
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17489
District Hospital Gummersbach
Gummersbach, 51643
BG Kliniken Bergmannstrost
Halle, 06112
Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
Hamburg, 21033
University Medicine Hamburg-Eppendorf
Hamburg, 220246
Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
Ludwigshafen, 67071
University Medicine Rostock
Rostock, 18055
Municipal Clinic Solingen
Solingen, 42663
About this study
Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.
Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.
Read more
Primary hypothesis:
In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
- Conditions
- Fracture of Metacarpal Bone
- Being tested
- Single Kirschner Wire, Double Kirschner Wire
- Keywords
- Metacarpal V Fractures, Single Kirschner Wires, Double Kirschner Wires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Kirschner WireDevice
Double Kirschner WireDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Kirschner Wire | Active comparator | Antegrade intramedullary fixation of with a single Kirschner wire. Receives: Device: Single Kirschner Wire |
| Double Kirschner Wire | Active comparator | Antegrade intramedullary fixation with double Kirschner wire. Receives: Device: Double Kirschner Wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score
Measured: 6 months after randomisation
Secondary outcomes (12)
Malposition or angulation in the frontal and sagittal planes of max. 5°
Measured: 6 months after randomisation
Shortening of the metacarpus >2mm
Measured: 6 months after randomisation
Palmar angulation >30°
Measured: 6 months after randomisation
Non-union/Pseudarthrosis
Measured: 6 months after randomisation
Limitation of fist closure
Measured: 6 months after randomisation
Flexion or extension lag
Measured: 6 months after randomisation
Pain intensity <10 points (VAS)
Measured: 6 months after randomisation
Duration of surgical intervention
Measured: 6 months after randomisation
Rate of re-interventions
Measured: 6 months after randomisation
Rate of infections
Measured: 6 months after randomisation
Rate of perforation/dislocation/break of the fracture fixation devices
Measured: 6 months after randomisation
Duration of inability to work
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Metacarpal 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
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Arthrose-Hilfe
- Responsible party
- Principal investigator, Prof. Dr. Andreas Eisenschenk, University Medicine Greifswald
- Investigators
- Andreas Eisenschenk, Prof. Dr., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803789
- Sponsor's protocol ID
- 1-2-KiWI
- Acronym
- 1-2-KiWI
- Status last verified
- Nov 2017
- First submitted
- 1 Mar 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
- ClinicalTrials.gov ID
- NCT01803789
- Acronym / sponsor ID
- 1-2-KiWI / 1-2-KiWI
- Conditions
- Fracture of Metacarpal Bone
- Keywords
- Metacarpal V Fractures, Single Kirschner Wires, Double Kirschner Wires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Deutsche Arthrose-Hilfe
- Study start
- May 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Mar 2013 (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.
Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.
Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.
Primary hypothesis:
In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Kirschner Wire | Active comparator | Device: Single Kirschner WireAntegrade intramedullary fixation of with a single Kirschner wire. |
| Double Kirschner Wire | Active comparator | Device: Double Kirschner WireAntegrade intramedullary fixation with double Kirschner wire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 years with a metacarpal V neck fracture with a palmar angulation and/or shortening and /or rotational deformity as determined on radiological diagnosis
- Trauma within 10 days before appearing in the study centre
- No specific medical treatment before
- Ability to fully understand the character and implications of the clinical trial
- Written or oral (in case of an injury of the dominant hand, if so attested by witnesses)consent
Key exclusion criteria (6 listed)
- Indications for conservative therapy
- Patient is not suitable for anaesthesia
- Other physical conditions or characteristics which made surgical interventions inappropriate or to risky (e.g. open fractures, polytrauma, pregnancy, acute infections, pathological fractures)
- Prior participation in this study (e.g. injury of the contralateral hand) or participation in other interventional studies with the same objective
- Physical or mental diseases which makes the consequent participation in diagnostic, therapy and the follow-up-examinations unlikely
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 |
|---|---|---|
| Single Kirschner Wire | Device | Single Kirschner Wire |
| Double Kirschner Wire | Device | Double Kirschner Wire |
Primary outcome
Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score
Time frame: 6 months after randomisation
12 secondary outcomes
Malposition or angulation in the frontal and sagittal planes of max. 5°
Time frame: 6 months after randomisation
Shortening of the metacarpus >2mm
Time frame: 6 months after randomisation
Palmar angulation >30°
Time frame: 6 months after randomisation
Non-union/Pseudarthrosis
Time frame: 6 months after randomisation
Limitation of fist closure
Time frame: 6 months after randomisation
Flexion or extension lag
Time frame: 6 months after randomisation
Pain intensity <10 points (VAS)
Time frame: 6 months after randomisation
Duration of surgical intervention
Time frame: 6 months after randomisation
Rate of re-interventions
Time frame: 6 months after randomisation
Rate of infections
Time frame: 6 months after randomisation
Rate of perforation/dislocation/break of the fracture fixation devices
Time frame: 6 months after randomisation
Duration of inability to work
Time frame: 6 months after randomisation
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
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Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
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RecruitingObservational study
The CARBO CARBON Study
Metacarpal Shaft Fractures, Greenhouse Gas Emissions
Not yet recruiting
Intramedullary Screw Fixation Versus Closed Reduction and Percutaneous Pinning With Cast Immobilization
Metacarpal Fracture, Phalanx Fracture
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.
Andreas Eisenschenk, Prof. Dr. principal investigator
University Medicine Greifswald
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Kirschner Wire and Double Kirschner Wire in people with Fracture of Metacarpal Bone, run by University Medicine Greifswald at 12 sites 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 5 inclusion and 6 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 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?
Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score (time frame: 6 months after randomisation). 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 6 Nov 2017.