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 |
| Secondary identifying numbers | N0192107595 |
- 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
Scientific
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
| mbhat1965@yahoo.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 13/12/2001 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
East Surrey Hospital
Redhill
RH1 5RH
United Kingdom
RH1 5RH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Queens Medical Centre University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
