1-2-KiWISingle Versus Double Kirschner Wires for Intramedullary Fixation of Metacarpal V Fractures
Single Kirschner Wire
+ Double Kirschner Wire
Treatment Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.292 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Sana Clinical Centre Lichtenberg
Berlin, GermanyVivantes Hospital Am Urban
Berlin, GermanyTrauma Hospital Berlin
Berlin, Germany