Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nabil Fahmy

ORCID ID

Contact details

Department of Orthopaedics
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes