Clinical trial NCT01803789: Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
Official title: Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Metacarpal Bone
Keywords: Metacarpal V Fractures
Single Kirschner Wires
Double Kirschner Wires
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsche Arthrose-Hilfe
First posted: 2013-03-04
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Malposition or angulation in the frontal and sagittal planes of max. 5°
timeFrame: 6 months after randomisation
measure: Shortening of the metacarpus >2mm
timeFrame: 6 months after randomisation
measure: Palmar angulation >30°
timeFrame: 6 months after randomisation
measure: Non-union/Pseudarthrosis
timeFrame: 6 months after randomisation
measure: Limitation of fist closure
timeFrame: 6 months after randomisation
measure: Flexion or extension lag
timeFrame: 6 months after randomisation
measure: Pain intensity <10 points (VAS)
timeFrame: 6 months after randomisation
measure: Duration of surgical intervention
timeFrame: 6 months after randomisation
measure: Rate of re-interventions
timeFrame: 6 months after randomisation
measure: Rate of infections
timeFrame: 6 months after randomisation
measure: Rate of perforation/dislocation/break of the fracture fixation devices
timeFrame: 6 months after randomisation
measure: Duration of inability to work
timeFrame: 6 months after randomisation
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: Sana Clinical Centre Lichtenberg
city: Berlin
country: Germany
facility: Vivantes Hospital Am Urban
city: Berlin
country: Germany
facility: Trauma Hospital Berlin
city: Düsseldorf
country: Germany
facility: University Medicine Düsseldorf
city: Gummersbach
country: Germany
facility: District Hospital Gummersbach
city: Halle
country: Germany
facility: BG Kliniken Bergmannstrost
city: Hamburg
country: Germany
facility: Berufsgenossenschaftliches Unfallkrankenhaus Hamburg
city: Hamburg
country: Germany
facility: University Medicine Hamburg-Eppendorf
city: Ludwigshafen
country: Germany
facility: Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen
city: Rostock
country: Germany
facility: University Medicine Rostock
city: Solingen
country: Germany
facility: Municipal Clinic Solingen
Study officials:
affiliation: University Medicine Greifswald
name: Andreas Eisenschenk, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: