Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Draper

ORCID ID

Contact details

University of Hull
School of Nursing Social Work and Applied Health Studies
Hull
HU6 7RX
United Kingdom
+44 (0)1482 465 018
p.r.draper@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ACLINIC

Study information

Scientific title

Acronym

Study hypothesis

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

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

Musculoskeletal injury

Intervention

Application of Hamilton-Russell traction

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

10/01/1993

Overall trial end date

30/09/1995

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fractured neck of femur deemed suitable for surgical fixation
2. Patient Consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

303 (added 11/01/10, see publication)

Participant exclusion criteria

1. Multiple fractures or injuries
2. Pressure sores
3. Absence, paralysis or fracture of lower limb

Recruitment start date

10/01/1993

Recruitment end date

30/09/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Hull
Hull
HU6 7RX
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

Draper P, Scott F. An evaluation of Hamilton-Russell traction in the pre-operative management of patients with hip fracture. Clin Eff Nurs 1997; 1: 179-188.

Publication citations

Additional files

Editorial Notes