Volar Locked Plating Versus Bridging External Fixation

Completed

• Conditions: Distal Radius Fracture

• Registration Number: NCT01062997
• Lead Sponsor: University Hospital, Akershus

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-06
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quick-DASH	2 year follow-up

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Sykehusveien 25, Nordbyhagen, Lorenskog, Norway

Akershus University Hospital

🇳🇴Sykehusveien 25, Nordbyhagen, Lorenskog, Norway