Contact information
Type
Scientific
Primary contact
Mr Muralidhar Bhat
ORCID ID
Contact details
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
mbhat1965@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192107595
Study information
Scientific title
Acronym
Study hypothesis
Currently, we feel that the methods used to perform k-wiring are incorrect. We wish to propose a new way to perform percutaneous k-wiring to improve the outcomes of this procedure in intra fractures of the distral radius. We also postulate that the outcomes from this procedure are significantly better with lesser complications than external fixation. This surgical procedure has significantly lower cost implications in the overall treatment of the patient with distral radial fractures.
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
Percutaneous k-wiring
Intervention
Laboratory study:
A: Percutaneous k-wiring
B: External fixation
The trial was registered when the trialist was at Queens Medical Centre Nottingham but the trial did not start.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Radiological outcome: X-rays at varying timepoints until union of the fracture. Various measures will be performed on these X-rays to ascertain the anatomical end point.
2. Clinical outcome: A detailed clinical examination at varying time points, measuring the objective end point with respect to range of movement, grip strength and complications will be recorded. A questionnaire to measure the subjective end point will be completed by the patient.
Secondary outcome measures
Overall trial start date
13/12/2001
Overall trial end date
01/12/2003
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Total number of subjects = 100.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
13/12/2001
Recruitment end date
01/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East Surrey Hospital
Redhill
RH1 5RH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Queens Medical Centre University Hospital 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