Clinical trial NCT01435070: Functional Outcome Following Fracture of the Distal Radius
Official title: A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Distal Radius Fractures
Keywords: Colles' fracture
Radius fracture
grip strength
pinch strength
range of movement
PRWE
DASH
EQ-5D
Kirschner wire
Volar locking plate
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: University Hospitals Coventry and Warwickshire NHS Trust
name: DePuy International
First posted: 2011-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management

Brief summary: Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.

At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.


Eligibility criteria: Inclusion Criteria:

* Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
* The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
* Aged over 18years (either sex) and able to give informed consent

Exclusion Criteria:

* The fracture extends more than 3 cm from the radio-carpal joint
* The fracture open with a Gustillo grading greater than 1
* There are contra-indications to general anaesthetic
* There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

Primary outcomes:
measure: Grip strength
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Pinch strength
timeFrame: 1 year post-operatively
measure: Wrist arc motion
timeFrame: 1 year post-operatively
measure: Patient rated wrist evaluation (PRWE)
timeFrame: 1 year post-operatively
measure: Disabilities of Arm, Shoulder and Hand Score (DASH)
timeFrame: 1 year post-operatively
measure: EQ-5D
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Warwick Medical School
state: Warwickshire
Study officials:
affiliation: Warwick Orthopaedics
name: Matthew Costa, FRCS, PhD
role: STUDY_CHAIR
affiliation: Warwick Orthopaedics
name: Juul Achten, PhD
role: STUDY_DIRECTOR
affiliation: Warwick Orthopaedics
name: Caroline E Plant, BSc, MBChB
role: PRINCIPAL_INVESTIGATOR
References: