Ruptured Achilles Tendon Trial: Comparing operative and non-operative management for patients with rupture of the Achilles tendon using immediate weight bearing

ISRCTN ISRCTN29053307
DOI https://doi.org/10.1186/ISRCTN29053307
Secondary identifying numbers NIHR CRN Study ID: 7416
Submission date
07/07/2010
Registration date
11/08/2010
Last edited
19/09/2013
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

Study website

Contact information

Mr Matthew Costa
Scientific

Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

matthew.costa@warwick.ac.uk

Study information

Study designPilot randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised pilot trial of operative versus non-operative management using immediate weight bearing rehabilitation
Study acronymRAT
Study objectivesThere 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(s)The Oxfordshire Research Ethics Committee (REC) A approved on the 27th November 2006 (ref: 06/Q1604/168)
Health condition(s) or problem(s) studiedAchilles tendon rupture
Intervention1. 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 typeOther
Primary outcome measureDisability Rating Index (DRI) at 2, 6, 12 weeks and 6 and 9 months
Secondary outcome measures1. EQ-5D
2. Achilles tendon rupture score (ATRS)
3. Complications

All outcomes measured at 2, 6, 12 weeks and 6 and 9 months.
Overall study start date01/08/2007
Completion date01/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Acute Achilles tendon rupture (presentation within 10 days)
2. Over 18 years
Key exclusion criteria1. 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
Date of first enrolment01/08/2007
Date of final enrolment01/09/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Medical School
Coventry
CV2 2DX
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

c/o Grants and Contracts Officer
Research Support Services
University House
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom

n.k.bains@warwick.ac.uk
http://www2.warwick.ac.uk/
ROR logo https://ror.org/01a77tt86

Funders

Funder type

Charity

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

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 results 05/04/2011 Yes No
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