Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

Study Overview
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Brief Summary
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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).

Official Title
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Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures

Conditions
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Fracture of Metacarpal Bone

Intervention / Treatment
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* Device: Single Kirschner Wire
* Device: Double Kirschner Wire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Kirschner Wire<br>Antegrade intramedullary fixation of with a single Kirschner wire. | Device: Single Kirschner Wire<br> <br> |
| Active Comparator: Double Kirschner Wire<br>Antegrade intramedullary fixation with double Kirschner wire. | Device: Double Kirschner Wire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score |  | 6 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malposition or angulation in the frontal and sagittal planes of max. 5° |  | 6 months after randomisation | 
| Shortening of the metacarpus >2mm |  | 6 months after randomisation | 
| Palmar angulation >30° |  | 6 months after randomisation | 
| Non-union/Pseudarthrosis |  | 6 months after randomisation | 
| Limitation of fist closure |  | 6 months after randomisation | 
| Flexion or extension lag |  | 6 months after randomisation | 
| Pain intensity <10 points (VAS) |  | 6 months after randomisation | 
| Duration of surgical intervention |  | 6 months after randomisation | 
| Rate of re-interventions |  | 6 months after randomisation | 
| Rate of infections |  | 6 months after randomisation | 
| Rate of perforation/dislocation/break of the fracture fixation devices |  | 6 months after randomisation | 
| Duration of inability to work |  | 6 months after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacarpal V Fractures, Single Kirschner Wires, Double Kirschner Wires