Single Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures (1-2-KiWI)

University Medicine Greifswald

Status

Completed

Conditions

Fracture of Metacarpal Bone

Treatments

Device: Double Kirschner Wire

Device: Single Kirschner Wire

Study type

Interventional

Funder types

Other

Identifiers

NCT01803789

1-2-KiWI

Details and patient eligibility

About

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).

Enrollment

292 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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