Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0244124359
Study information
Scientific title
Function versus position of the wrist following distal radial fracture
Acronym
Study hypothesis
1. To investigate whether the end result following k-wire fixation of the distal radius changes depending upon the position of the hand.
2. To establish whether time to recovery differs significantly depending upon the position of the hand.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Injury, Occupational Diseases, Poisoning: Radial fracture
Intervention
Patients with distal radial fractures undergoing reduction and k-wire fixation are randomised to dorsi or palmar flexion in plaster of Paris (POP). Upon removal of POP, grip test is measured using a Jamar Dynamometer. At 8 weeks, grip strength is measured again and the test is repeated at 17 weeks.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Grip strength
2. Range of motion
3. Radiological outcomes
Secondary outcome measures
Not provided at time of registration
Overall trial start date
06/03/2003
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Consecutive patients with displaced distal radial fracture undergoing reduction and k-wire fixation.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients with severe rheumatoid arthritis
2. Previous articular surgery
3. Previous injury to the same wrist
4. Less than 20 ° - 30 ° flexion or extension after k-wire fixation
Recruitment start date
06/03/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockport NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary