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Long Term Follow up of the DVR-A Locking Plate

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
De Puy
Global Diagnostics
Information provided by:
Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01122628
First received: May 12, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Distal Radial Fractures Treated With a DVR-A Locking Plate
 Device: ORIF with DVR-A locking plate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • DASH score [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    Disability of arm shoulder and hand score. This is a patient administered validated score

  • Pain [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Complications [ Time Frame: One year or more post surgery ] [ Designated as safety issue: Yes ]
    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

  • Radiographic appearance [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    Review of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change

  • EQ 5D [ Time Frame: More than one year post surgery ] [ Designated as safety issue: No ]
    Euroqual 5D is a patient administered general health questionaire that is validated.

  • Grip Strength [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    Measured by a dynomometer and referenced to the non operated side

  • Range of motion [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    Measured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes

  • Pain [ Time Frame: One year or more post surgery ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Treatment between Jan 2005 and March 2009

Exclusion Criteria:

  • Under 16
  • Unable to consent
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122628

Locations
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
De Puy
Global Diagnostics
Investigators
Principal Investigator: Adrian J Chojnowski Norfolk and Norwich University Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Adrian Chojnowski - Consultant Orthopaedic Surgeon, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01122628     History of Changes
Other Study ID Numbers: 2009ORTH11, ISS2009050
Study First Received: May 12, 2010
Last Updated: May 12, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
Distal Radial Fracture
Volar Locking Plate

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013