Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

August 26, 2019 updated by: Haukeland University Hospital

A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.

The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Voss
      • Bergen, Voss, Norway, 5700
        • Orthopaedic depatment, Voss hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with dislocated extraarticular distal radius fracture age 18-70 years

Exclusion Criteria:

  • Cognitively impaired
  • Drug abuse
  • Congenital bone disease
  • Earlier wrist injury
  • Open fracture, Gustilo-Anderson type 3
  • Pathological fractures( except osteoporotic fractures)
  • Tourists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Volar locked plating
One group with distal radius fracture is operated with Locking plate
Device: Volar locked plating
Operative treatment of distal radius fracture with volar locking plate
Other Names:
  • DVR Anatomic plate, Hand Innovations, De Puy
Active Comparator: Hoffman external fixator
One group with distal radius fracture is operated with Hoffman external fixator
Device: Hoffman external fixator
Patients with distal radius fracture operated with Hoffman external fixator
Other Names:
  • Bridging Hoffman II Compact, Stryker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient rated wrist evaluation (PRWE)score
Time Frame: 3 months
3 months
Patient rated wrist evaluation (PRWE)score
Time Frame: 6 weeks
6 weeks
Patient rated wrist evaluation (PRWE)score
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick-DASH score
Time Frame: 6 weeks, 3 and 12 months
6 weeks, 3 and 12 months
Pain VAS-score
Time Frame: 6 weeks, 3 and 12 months
6 weeks, 3 and 12 months
Complications
Time Frame: 6 weeks, 3 and 12 months
Number of patients with per- and postoperative complications will be registrated. Types of expected complications: Tendon rupture, Tendon irritation, Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Screw displacement/screw loosening, Delayed fracture union
6 weeks, 3 and 12 months
Radiographic evaluation
Time Frame: 6 weeks and 12 months
Palmar tilt, Radial inclination, Ulnar variance, Fracture union
6 weeks and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Helse-Bergen HF

Investigators

  • Principal Investigator: Trine Ludvigsen, Md

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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