Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes