Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Completed
NCT Number: NCT01122628
Long Term Follow up of the DVR-A Locking Plate
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.
Completed
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Notify MeKey information
Age range
16 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Treatment between Jan 2005 and March 2009
Exclusion criteria
- Under 16
- Unable to consent
- Pregnant
Treatment and study plan
ORIF with DVR-A locking plate
DeviceSize, length of plate and number os screws decided by operating surgeon
Other names: Distal volar radial anatomic plate, Hand inovations
Primary outcomes
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DASH score
Time frame: One year or more post surgery
Disability of arm shoulder and hand score. This is a patient administered validated score
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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
Secondary outcomes
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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
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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
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EQ 5D
Time frame: More than one year post surgery
Euroqual 5D is a patient administered general health questionaire that is validated.
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Grip Strength
Time frame: One year or more post surgery
Measured by a dynomometer and referenced to the non operated side
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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
-
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
Sponsors and collaborators
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Other
Collaborators
- DePuy International
- Global Diagnostics UK
Registry information
Official study title
Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 13, 2010
- Registry last updated
- Aug 23, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.