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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01122628
Enrollment
136
Registered
2010-05-13
Start date
2010-05-31
Completion date
2012-10-31
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radial Fractures Treated With a DVR-A Locking Plate

Keywords

Distal Radial Fracture, Volar Locking Plate

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.

Interventions

DEVICEORIF with DVR-A locking plate

Size, length of plate and number os screws decided by operating surgeon

Sponsors

DePuy International
CollaboratorINDUSTRY
Global Diagnostics UK
CollaboratorOTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Treatment between Jan 2005 and March 2009

Exclusion criteria

* Under 16 * Unable to consent * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
DASH scoreOne year or more post surgeryDisability of arm shoulder and hand score. This is a patient administered validated score
PainOne year or more post surgeryA 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

MeasureTime frameDescription
EQ 5DMore than one year post surgeryEuroqual 5D is a patient administered general health questionaire that is validated.
Grip StrengthOne year or more post surgeryMeasured by a dynomometer and referenced to the non operated side
ComplicationsOne year or more post surgeryExamination 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
PainOne year or more post surgeryA 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
Range of motionOne year or more post surgeryMeasured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes
Radiographic appearanceOne year or more post surgeryReview of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026