Long Term Follow up of the DVR-A Locking Plate

Study Overview
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Brief Summary
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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.

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

Conditions
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Distal Radial Fractures Treated With a DVR-A Locking Plate

Intervention / Treatment
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* Device: ORIF with DVR-A locking plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment between Jan 2005 and March 2009 Exclusion Criteria: Under 16 Unable to consent Pregnant

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DVR-A<br>Patients with a distal radial fracture treated with a DVR-A locking plate | Device: ORIF with DVR-A locking plate<br>* Size, length of plate and number os screws decided by operating surgeon<br>* Other names: Hand inovations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | 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 | Review of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change | One year or more post surgery | 
| EQ 5D | Euroqual 5D is a patient administered general health questionaire that is validated. | More than one year post surgery | 
| Grip Strength | Measured by a dynomometer and referenced to the non operated side | One year or more post surgery | 
| Range of motion | Measured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radial Fracture, Volar Locking Plate