Long Term Follow up of the DVR-A Locking Plate

Completed

• Conditions: Distal Radial Fractures Treated With a DVR-A Locking Plate
• Interventions: Device: ORIF with DVR-A locking plate

• Registration Number: NCT01122628
• Lead Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Treatment between Jan 2005 and March 2009

Exclusion Criteria

• Under 16
• Unable to consent
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DVR-A	ORIF with DVR-A locking plate	Patients with a distal radial fracture treated with a DVR-A locking plate

Primary Outcome Measures

Name	Time	Method
Pain	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
DASH score	One year or more post surgery	Disability of arm shoulder and hand score. This is a patient administered validated score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom