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NCT01062997 Clinical Trial

Volar Locked Plating Versus Bridging External Fixation

Distal Radius Fracture Clinical Trial

Official title:
Volar Locked Plating Versus Bridging External Fixation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01062997
Other study ID # S-09101a 2009/2172
Secondary ID
Status Completed
Phase N/A
First received February 4, 2010
Last updated August 6, 2016
Start date September 2009
Est. completion date April 2016

Study information
Verified date August 2016
Source University Hospital, Akershus
Contact n/a
Is FDA regulated No
Health authority The National Committees for Research Ethics: Norway
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Akershus University Hospital Sykehusveien 25, Nordbyhagen Lorenskog

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Akershus Haukeland University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quick-DASH 2 year follow-up No
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