Long Term Follow up of the DVR-A Locking Plate

August 21, 2018 updated by: Norfolk and Norwich University Hospitals NHS Foundation Trust

Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures

The surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. This results in improved fixation and stabilisation of the fracture fragments allowing early movement.

This type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. The Norfolk and Norwich Hospital has treated over 250 distal radial fractures with this type of plate. The investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

136

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

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust

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 and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be taken from a population consisting of all patients who have undergone distal radial fracture treatement with a DVR-A locking plate at the norfolk and Norwich University hospitals NHS Foundation Trust

Description

Inclusion Criteria:

  • Treatment between Jan 2005 and March 2009

Exclusion Criteria:

  • Under 16
  • Unable to consent
  • Pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DVR-A
Patients with a distal radial fracture treated with a DVR-A locking plate
Device: ORIF with DVR-A locking plate
Size, length of plate and number os screws decided by operating surgeon
Other Names:
  • Distal volar radial anatomic plate
  • Hand inovations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH score
Time Frame: One year or more post surgery
Disability of arm shoulder and hand score. This is a patient administered validated score
One year or more post surgery
Pain
Time Frame: One year or more post surgery
A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable
One year or more post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: One year or more post surgery
A patient administered visual analogue scale numbered 1-10. A mark can be placed anywhere along the line with a score of 0 indicating no pain and 10 the worst pain imaginable
One year or more post surgery
Complications
Time Frame: One year or more post surgery
Examination and questioning by a hand therapist to pick up complications. Prompting for tendon irritation or rupture, neurovascular injury, plate or screw failure, hardware removal and infection
One year or more post surgery
Radiographic appearance
Time Frame: One year or more post surgery
Review of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change
One year or more post surgery
EQ 5D
Time Frame: More than one year post surgery
Euroqual 5D is a patient administered general health questionaire that is validated.
More than one year post surgery
Grip Strength
Time Frame: One year or more post surgery
Measured by a dynomometer and referenced to the non operated side
One year or more post surgery
Range of motion
Time Frame: One year or more post surgery
Measured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes
One year or more post surgery

Collaborators and Investigators

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

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborators

DePuy International
Global Diagnostics UK

Investigators

  • Principal Investigator: Adrian J Chojnowski, Norfolk and Norwich University Hospitals NHS Foundation Trust

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

May 1, 2010

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 12, 2010

First Posted (ESTIMATE)

May 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009ORTH11
  • ISS2009050 (OTHER_GRANT: De Puy)

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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