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

Not Applicable

Completed

• Conditions: Fracture of Metacarpal Bone
• Interventions: Device: Single Kirschner Wire; Device: Double Kirschner Wire

• Registration Number: NCT01803789
• Lead Sponsor: University Medicine Greifswald

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Study Start: 2013-05
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Kirschner Wire	Single Kirschner Wire	Antegrade intramedullary fixation of with a single Kirschner wire.
Double Kirschner Wire	Double Kirschner Wire	Antegrade intramedullary fixation with double Kirschner wire.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of perforation/dislocation/break of the fracture fixation devices	6 months after randomisation
Duration of inability to work	6 months after randomisation
Flexion or extension lag	6 months after randomisation
Pain intensity <10 points (VAS)	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
Duration of surgical intervention	6 months after randomisation
Limitation of fist closure	6 months after randomisation
Rate of infections	6 months after randomisation
Malposition or angulation in the frontal and sagittal planes of max. 5°	6 months after randomisation
Rate of re-interventions	6 months after randomisation

Trial Locations

Locations (12)

Sana Clinical Centre Lichtenberg; 🇩🇪 Berlin, Germany

Vivantes Hospital Am Urban; 🇩🇪 Berlin, Germany

Trauma Hospital Berlin; 🇩🇪 Berlin, Germany

University Medicine Düsseldorf; 🇩🇪 Düsseldorf, Germany

Berufsgenossenschaftliches Unfallkrankenhaus Hamburg; 🇩🇪 Hamburg, Germany

District Hospital Gummersbach; 🇩🇪 Gummersbach, Germany

BG Kliniken Bergmannstrost; 🇩🇪 Halle, Germany

Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

University Medicine Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University Medicine Rostock; 🇩🇪 Rostock, Germany

Municipal Clinic Solingen; 🇩🇪 Solingen, Germany

University Medicine Greifswald; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany