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
• 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

• Distal Radius Fracture
• Radius Fractures

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