Overview

This trial is active, not recruiting.

Condition distal radius fracture
Sponsor University Hospital, Akershus
Collaborator University of Oslo
Start date September 2009
End date December 2015
Trial size 140 participants
Trial identifier NCT01062997, S-09101a 2009/2172

Summary

A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3.

Hypothesis:

There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Quick-DASH
time frame: 2 year follow-up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA). - All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion. Exclusion Criteria: - Gustillo-Anderson type III open fractures - Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity - Dementia - Congenital anomaly - Bilateral radius fracture - Pathological fracture other than osteoporotic fracture - Congenital bone disease (for example osteogenesis imperfecta) - Age below 18 and above 70 - Disabling nury to other parts og the movement apparatus at the same time as the current injury

Additional Information

Official title Volar Locked Plating Versus Bridging External Fixation
Description We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Hospital, Akershus.