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

University of Hull
School of Nursing Social Work and Applied Health Studies
Hull
HU6 7RX
United Kingdom

Phone +44 (0)1482 465 018
Email p.r.draper@hull.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWe 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) studiedMusculoskeletal injury
InterventionApplication of Hamilton-Russell traction
Intervention typeOther
Primary outcome measure1. Pain (measured by Bourbonnais pain ruler, a visual analogue scale)
2. Pressure sore (Torrance 5 point scale)
Secondary outcome measuresNot provided at time of registration
Overall study start date10/01/1993
Completion date30/09/1995

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants303 (added 11/01/10, see publication)
Key inclusion criteria1. Fractured neck of femur deemed suitable for surgical fixation
2. Patient Consent
Key exclusion criteria1. Multiple fractures or injuries
2. Pressure sores
3. Absence, paralysis or fracture of lower limb
Date of first enrolment10/01/1993
Date of final enrolment30/09/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Hull
Hull
HU6 7RX
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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