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

NCT01803789 | Completed

• 1 other identifier: 1-2-KiWI
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 12

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).

Conditions

Fracture of Metacarpal Bone

Keywords

Metacarpal V Fractures; Single Kirschner Wires; Double Kirschner Wires

Outcome Measures

Primary Outcomes (1)

• Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score

  6 months after randomisation

Secondary Outcomes (12)

• 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

Study Arms (2)

Single Kirschner Wire

ACTIVE COMPARATOR

Antegrade intramedullary fixation of with a single Kirschner wire.

Device: Single Kirschner Wire

Double Kirschner Wire

ACTIVE COMPARATOR

Antegrade intramedullary fixation with double Kirschner wire.

Device: Double Kirschner Wire

Interventions

Single Kirschner Wire DEVICE

Single Kirschner Wire

Double Kirschner Wire DEVICE

Double Kirschner Wire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Deutsche Arthrose-Hilfe: collaborator

Study Sites (12)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

Sana Clinical Centre Lichtenberg

Berlin, 10365, Germany

Location

Vivantes Hospital Am Urban

Berlin, 10967, Germany

Location

Trauma Hospital Berlin

Berlin, 12683, Germany

Location

University Medicine Düsseldorf

Düsseldorf, 40225, Germany

Location

District Hospital Gummersbach

Gummersbach, 51643, Germany

Location

BG Kliniken Bergmannstrost

Halle, 06112, Germany

Location

Berufsgenossenschaftliches Unfallkrankenhaus Hamburg

Hamburg, 21033, Germany

Location

University Medicine Hamburg-Eppendorf

Hamburg, 220246, Germany

Location

Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen

Ludwigshafen, 67071, Germany

Location

University Medicine Rostock

Rostock, 18055, Germany

Location

Municipal Clinic Solingen

Solingen, 42663, Germany

Location

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Andreas Eisenschenk, Prof. Dr.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 4, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)