Long Term Follow up of the DVR-A Locking Plate
Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
2 other identifiers
observational
136
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 12, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedAugust 23, 2018
August 1, 2018
2.4 years
May 12, 2010
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
DASH score
Disability of arm shoulder and hand score. This is a patient administered validated score
One year or more post surgery
Pain
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 Outcomes (6)
Complications
One year or more post surgery
Radiographic appearance
One year or more post surgery
EQ 5D
More than one year post surgery
Grip Strength
One year or more post surgery
Range of motion
One year or more post surgery
- +1 more secondary outcomes
Study Arms (1)
DVR-A
Patients with a distal radial fracture treated with a DVR-A locking plate
Interventions
Size, length of plate and number os screws decided by operating surgeon
Eligibility Criteria
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
You may qualify if:
- Treatment between Jan 2005 and March 2009
You may not qualify if:
- Under 16
- Unable to consent
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trustlead
- DePuy Internationalcollaborator
- Global Diagnostics UKcollaborator
Study Sites (1)
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian J Chojnowski
Norfolk and Norwich University Hospitals NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2010
First Posted
May 13, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
August 23, 2018
Record last verified: 2018-08