A clinical trial of Hamilton-Russell traction on a) incidence of pressure sores, and b) pre-operative pain, in patients with fractured neck of femur.
| ISRCTN | ISRCTN62558708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62558708 |
| Secondary identifying numbers | ACLINIC |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 11/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Draper
Scientific
Scientific
University of Hull
School of Nursing Social Work and Applied Health Studies
Hull
HU6 7RX
United Kingdom
| Phone | +44 (0)1482 465 018 |
|---|---|
| p.r.draper@hull.ac.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 | We propose to evaluate the effect of Hamilton-Russell traction on (a) the peri-operative incidence of pressure sores and (b) pre-operative pain, in patients with fractured neck of femur. There is little evidence to suggest that traction confers any advantage in the pre-operative period, upon patients who receive it. Furthermore, its use may increase the risk of pressure sore development. If the data from the study supports the hypothesis that Hamilton-Russell traction has no beneficial effect, we can strongly argue for its discontinuation. Money currently spent on traction kits will be saved. Furthermore, patient suffering will be reduced through a reduction in the development of pressure sores. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal injury |
| Intervention | Application of Hamilton-Russell traction |
| Intervention type | Other |
| Primary outcome measure | 1. Pain (measured by Bourbonnais pain ruler, a visual analogue scale) 2. Pressure sore (Torrance 5 point scale) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/01/1993 |
| Completion date | 30/09/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 303 (added 11/01/10, see publication) |
| Key inclusion criteria | 1. Fractured neck of femur deemed suitable for surgical fixation 2. Patient Consent |
| Key exclusion criteria | 1. Multiple fractures or injuries 2. Pressure sores 3. Absence, paralysis or fracture of lower limb |
| Date of first enrolment | 10/01/1993 |
| Date of final enrolment | 30/09/1995 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Hull
Hull
HU6 7RX
United Kingdom
HU6 7RX
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/1997 | Yes | No |
