|
ISRCTN
|
ISRCTN29053307
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Ruptured Achilles Tendon Trial: Comparing operative and non-operative management for patients with rupture of the Achilles tendon using immediate weight bearing
|
|
Scientific title
|
A randomised pilot trial of operative versus non-operative management using immediate weight bearing rehabilitation
|
|
Acronym
|
RAT
|
|
Serial number at source
|
NIHR CRN Study ID: 7416
|
|
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.
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Achilles tendon rupture
|
|
Participants - inclusion criteria
|
1. Acute Achilles tendon rupture (presentation within 10 days)
2. Over 18 years
|
|
Participants - 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
|
|
Anticipated start date
|
01/08/2007
|
|
Anticipated end date
|
01/09/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
20
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Disability Rating Index (DRI) at 2, 6, 12 weeks and 6 and 9 months
|
|
Secondary outcome measure(s)
|
1. EQ-5D
2. Achilles tendon rupture score (ATRS)
3. Complications
All outcomes measured at 2, 6, 12 weeks and 6 and 9 months.
|
|
Sources of funding
|
British Orthopaedic Foundation (UK) (ref: BOF 03:07)
|
|
Trial website
|
http://www2.warwick.ac.uk/fac/med/research/csri/orthopaedics/research/primary/rat/
|
|
Publications
|
|
|
Contact name
|
Mr
Matthew
Costa
|
|
Address
|
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
|
|
City/town
|
Coventry
|
|
Zip/Postcode
|
CV2 2DX
|
|
Country
|
United Kingdom
|
|
Email
|
matthew.costa@warwick.ac.uk
|
|
Sponsor
|
University of Warwick (UK)
|
|
Address
|
c/o Grants and Contracts Officer
Research Support Services
University House
Kirby Corner Road
|
|
City/town
|
Coventry
|
|
Zip/Postcode
|
CV4 8UW
|
|
Country
|
United Kingdom
|
|
Email
|
n.k.bains@warwick.ac.uk
|
|
Sponsor website:
|
http://www2.warwick.ac.uk/
|
|
Date applied
|
07/07/2010
|
|
Last edited
|
11/08/2010
|
|
Date ISRCTN assigned
|
11/08/2010
|
