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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21466700
Publication citations
-
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.