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
Contact information
Mr Matthew Costa
Scientific
Scientific
Warwick Medical School
Clinical Sciences Research Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
matthew.costa@warwick.ac.uk |
Study information
Study design | Pilot randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised pilot trial of operative versus non-operative management using immediate weight bearing rehabilitation |
Study acronym | RAT |
Study objectives | 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(s) | The Oxfordshire Research Ethics Committee (REC) A approved on the 27th November 2006 (ref: 06/Q1604/168) |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/08/2007 |
Completion date | 01/09/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | 1. Acute Achilles tendon rupture (presentation within 10 days) 2. Over 18 years |
Key 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 |
Date of first enrolment | 01/08/2007 |
Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Medical School
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Sponsor information
University of Warwick (UK)
University/education
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 | |
Website | http://www2.warwick.ac.uk/ |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |