Operative versus Non-Operative Treatment for Achilles Tendon Rupture.
Research type
Research Study
Full title
Operative versus Non-Operative Treatment for Achilles Tendon Rupture: Long Term Followup of Patients in a Previous Randomised Controlled Trial.
IRAS ID
224857
Contact name
John Keating
Contact email
Sponsor organisation
NRS Generic Review Manager
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
There has been longstanding debate around the choice of operative or non-operative treatment for ruptures of the achilles tendon. Multiple prospective, randomised studies have addressed this research question, but they only report short term outcomes at one or two years, leaving uncertainty as to potential differences in outcomes in the longer term. One such prospective randomised controlled trial was undertaken in Edinburgh between 2000 and 2004, where 80 patients were randomised to receive either operative or non-operative treatment. One outcome measure in this study was the Short Musculoskeletal Function Assessment (SMFA) questionnaire. Like other similar studies, patients were followed for up to one year after their injury. This showed early difference in functional outcome but no difference at one year. The current study aims to assess patient self-reported functional outcomes at the present time (ie >12-16 years after their treatment) by contacting them and asking them to complete a set of questionnaires (SMFA; EQ5D; Achilles Tendon Rupture Score - ATRS; satisfaction Likert scale and adverse events including re-rupture, contralateral rupture and DVT/PE). The collection of SMFA data will allow direct comparison with the results of the initial study to report on changes in patient function with the passage of time. The ATRS is a more modern injury-specific score described after the previous study. The EQ5D score will give information about general quality of life and the satisfaction scale will allow us to understand how satisfied patients are with their ankle in the longer term. Information about longer term re-rupture rates in these patients will also be reported. Patients will not be physically reviewed for this study and will not undergo any treatment intervention or medical management.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0256
Date of REC Opinion
11 Jul 2017
REC opinion
Favourable Opinion