Distal Radial Fractures Treated With a DVR-A Locking Plate Clinical Trial
Official title:
Long Term Follow Up Study Into The Use Of The DVR-A Locking Plate In The Treatment Of Distal Radial Fractures
| NCT number | NCT01122628 |
| Other study ID # | 2009ORTH11 |
| Secondary ID | ISS2009050 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2010 |
| Est. completion date | October 2012 |
| Verified date | August 2018 |
| Source | Norfolk and Norwich University Hospitals NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Treatment between Jan 2005 and March 2009 Exclusion Criteria: - Under 16 - Unable to consent - Pregnant |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk |
| Lead Sponsor | Collaborator |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | DePuy International, Global Diagnostics UK |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DASH score | Disability of arm shoulder and hand score. This is a patient administered validated score | One year or more post surgery | |
| Primary | 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 | 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 | |
| Secondary | Radiographic appearance | Review of xrays to measure radial inclination, volar tilt,, shortening, articular stepoff and degenerative change | One year or more post surgery | |
| Secondary | EQ 5D | Euroqual 5D is a patient administered general health questionaire that is validated. | More than one year post surgery | |
| Secondary | Grip Strength | Measured by a dynomometer and referenced to the non operated side | One year or more post surgery | |
| Secondary | Range of motion | Measured with a goniometer. Measurements taken of movements in the axial,coronal and sagital planes | One year or more post surgery | |
| Secondary | 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 |