A proposective randomised clinical trial comparing the outcomes of external fixation and a new concept of percutaneous k-wiring

ISRCTN	ISRCTN22284289
DOI	https://doi.org/10.1186/ISRCTN22284289
Protocol serial number	N0192107595
Sponsor	Department of Health (UK)
Funder	Queens Medical Centre University Hospital NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 27/10/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Muralidhar Bhat
Scientific

East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Email	mbhat1965@yahoo.co.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)
Completion date	01/12/2003
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Total number of subjects = 100.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	13/12/2001
Date of final enrolment	01/12/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

East Surrey Hospital

Redhill
RH1 5RH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan