Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/07/2010
Date assigned
11/08/2010
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www2.warwick.ac.uk/fac/med/research/csri/orthopaedics/research/primary/rat/

Contact information

Type

Scientific

Primary contact

Mr Matthew Costa

ORCID ID

Contact details

Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
matthew.costa@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NIHR CRN Study ID: 7416

Study information

Scientific title

A randomised pilot trial of operative versus non-operative management using immediate weight bearing rehabilitation

Acronym

RAT

Study hypothesis

There is no difference in Disability Rating Index (DRI) scores at nine months between patients managed operatively compared to patients managed non-operatively using an immediate weight bearing programme.

Ethics approval

The Oxfordshire Research Ethics Committee (REC) A approved on the 27th November 2006 (ref: 06/Q1604/168)

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Achilles tendon rupture

Intervention

1. Operative Managment: Method left to the discretion of the operating surgeon, followed by immediate weight bearing within an orthotic boot for eight weeks
2. Non-operative management: Same rehabilitation as above

Secondary Sponsor:
University Hospitals of Coventry and Warwickshire NHS Trust
Research and Development Department
Clifford Bridge Road
Coventry
CV4 8UW
United Kingdom

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Disability Rating Index (DRI) at 2, 6, 12 weeks and 6 and 9 months

Secondary outcome measures

1. EQ-5D
2. Achilles tendon rupture score (ATRS)
3. Complications

All outcomes measured at 2, 6, 12 weeks and 6 and 9 months.

Overall trial start date

01/08/2007

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute Achilles tendon rupture (presentation within 10 days)
2. Over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Re-rupture
2. Any other serious injuries to either lower limb that would interfere with rehabilitation
3. Poor circulation in the legs
4. Contraindication to surgery

Recruitment start date

01/08/2007

Recruitment end date

01/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warwick Medical School
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Grants and Contracts Officer
Research Support Services
University House
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom
n.k.bains@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Charity

Funder name

British Orthopaedic Foundation (UK) (ref: BOF 03:07)

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21466700

Publication citations

  1. Results

    Kearney RS, Achten J, Parsons NR, Costa ML, The comprehensive cohort model in a pilot trial in orthopaedic trauma., BMC Med Res Methodol, 2011, 11, 39, doi: 10.1186/1471-2288-11-39.

Additional files

Editorial Notes