Fracture of Metacarpal Bone Clinical Trial
— 1-2-KiWIOfficial title:
Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
| Verified date | November 2017 |
| Source | University Medicine Greifswald |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 292 |
| Est. completion date | July 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Sana Clinical Centre Lichtenberg | Berlin | |
| Germany | Trauma Hospital Berlin | Berlin | |
| Germany | Vivantes Hospital Am Urban | Berlin | |
| Germany | University Medicine Düsseldorf | Düsseldorf | |
| Germany | University Medicine Greifswald | Greifswald | Mecklenburg-Vorpommern |
| Germany | District Hospital Gummersbach | Gummersbach | |
| Germany | BG Kliniken Bergmannstrost | Halle | |
| Germany | Berufsgenossenschaftliches Unfallkrankenhaus Hamburg | Hamburg | |
| Germany | University Medicine Hamburg-Eppendorf | Hamburg | |
| Germany | Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen | Ludwigshafen | |
| Germany | University Medicine Rostock | Rostock | |
| Germany | Municipal Clinic Solingen | Solingen |
| Lead Sponsor | Collaborator |
|---|---|
| University Medicine Greifswald | Deutsche Arthrose-Hilfe |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score | 6 months after randomisation | ||
| Secondary | Malposition or angulation in the frontal and sagittal planes of max. 5° | 6 months after randomisation | ||
| Secondary | Shortening of the metacarpus >2mm | 6 months after randomisation | ||
| Secondary | Palmar angulation >30° | 6 months after randomisation | ||
| Secondary | Non-union/Pseudarthrosis | 6 months after randomisation | ||
| Secondary | Limitation of fist closure | 6 months after randomisation | ||
| Secondary | Flexion or extension lag | 6 months after randomisation | ||
| Secondary | Pain intensity <10 points (VAS) | 6 months after randomisation | ||
| Secondary | Duration of surgical intervention | 6 months after randomisation | ||
| Secondary | Rate of re-interventions | 6 months after randomisation | ||
| Secondary | Rate of infections | 6 months after randomisation | ||
| Secondary | Rate of perforation/dislocation/break of the fracture fixation devices | 6 months after randomisation | ||
| Secondary | Duration of inability to work | 6 months after randomisation |