Clinical Trial: Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Functional Outcomes After Conservative Management of the Acutely Ruptured Achilles Tendon in the Under 60 Age Group. A Randomised Controlled Trial Comparing Standard Conservative Management With Accel

Brief Summary: The purpose of this study is to directly compare traditional plaster treatment with early weightbearing in a walking boot for the non operative treatment of acute achilles tendon rupture.

Detailed Summary:

This injury has traditionally been treated in a plaster cast applied to the leg for a period of 10 weeks which allows the tendon to heal, or by an operation to repair the tendon. Research undertaken in the investigators department has shown that patients treated with surgery or with a plaster had similar chance of re-rupture of the tendon after treatment and gain a similar recovery. The investigators therefore now manage these injuries in a plaster.

More recently, further research has shown that a new type of non-surgical rehabilitation programme, which is quicker than the traditional non-surgical programme, gave a tendon re-rupture rate that was similar to that after surgical treatment. This new rehabilitation programme uses a walking boot fitted with a heel-raise (instead of the traditional plaster). The potential benefit of this quicker rehabilitation programme is that it allows the patient to put weight through the leg immediately, whereas patients treated with the traditional plaster cast non-surgical treatment cannot weight bear (this means that they are kept non-weightbearing and therefore have to use crutches) for the first 8 weeks. Later on in the programme, it also allows the patient to remove the boot to undertake supervised exercises with a physiotherapist, which cannot be done with a plaster. Finally, the time spent in the walking boot in this new, quicker rehabilitation programme is 8 weeks while that spent in plaster is 10 weeks. This new non-surgical, quicker rehabilitation programme is referred to as the accelerated non-surgical programme hereafter. There are no known increased risks with the accelerated rehabilitation programme.

Current Primary Outcome: Plantarflexion, dorsiflexion, inversion and eversion muscle power measured isokinetically with Biodex dynamometer. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of thromboembolic events [ Time Frame: 1 year ]
  Incidence of radiologically confirmed thromboembolic events within one year of injury is to be reported for each group.
• Ankle and subtalar motion [ Time Frame: 10, 26 and 52 weeks ]
  Ankle motion is to be measured using a goniometer for each patient while subtalar motion is to be clinically assessed. Range of motion will be reported for each group as measure of central tendency (median or mean) and standard deviation or interquartile range.
• Calf circumference [ Time Frame: 10, 26 and 52 weeks ]
  Measured in centimetres at a point 11 centimetres below the tibial tuberosity. Both sides are measured and the affected (injured) side is compared to the unaffected (uninjured) side for each patient, yielding a relative calf circumference for the affected side. Relative circumference can then be compared across the two groups and reported for each group as a measure of central tendency along with standard deviation/interquartile range..
• Visual Analogue Score (VAS) for pain [ Time Frame: Initial review, 4,8,10,26,52 weeks. ]
  VAS scored between 0 and 10. Patients asked to circle an integer between 0 and 10 to indicate their pain level, with 0 indicating no pain and 10 indicating severe pain. Scores to be reported for each group (arm of trial) as measure of central tendency (mean/median) and standard deviations/interquartile range.
• Foot and Ankle Outcomes Questionnaire [ Time Frame: At the initial review, upon enrolment in the study, patients are asked to complete the questionnaire detailing their immediate pre-injury status (ie status one day before injury). Then reassessed at 26 and 52 weeks. ]
  American Academy of Orthopaedic Surgeons (AAOS) SMFA form questionnaire (August 2005 version based on version 2.0 Foot and Ankles Outcomes Instrument. This consists of 25 questions with patients asked to indicate the answer that best applies to their situation. Responses are used to calculate a score and scores for each group will be reported as a measure of central tendency (median/mean) with standard deviations/interquartile ranges.
• Achilles Tendon Total Rupture Score (ATRS) [ Time Frame: At the initial review, upon enrolment in the study, patients are asked to complete the questionnaire detailing their immediate pre-injury status (ie status one day before injury). Then reassessed at 26 and 52 weeks ]
  This is a validated score consisting of 10 questions scored 0 to 10 (whole numbers only) with 0 indicating no limitation and 10 indicating maximal limitation. Data to be analysed and presented as measure of central tendency (median/mean) and standard deviations/interquartile ranges for patients in each group.
• SMFA (Short Musculoskeletal Function Assessment Questionnaire) [ Time Frame: At the initial review, upon enrolment in the study, patients are asked to complete the questionnaire detailing their immediate pre-injury status (ie status one day before injury). Then reassessed at 26 and 52 weeks. ]
  46 question score. Patients are asked to tick boxes labelled between 1 (indicating good function/no problems) and 5 (poor function/significant problems) for each question and the responses are used to calculate a "dysfunction index", a "bother index" and an "overall SMFA score". These will be reported for each group with measure of central tendency (mean/median) and standard deviations/interquartile range.
• Return to work. [ Time Frame: 10,26,52 weeks. ]
  Time to initial return to work activity measured in days from date of injury. To be reported as the measure of central tendency (mean or median) and standard deviation or interquartile range, for each group (arm of trial). Patients will be asked whether they have returned to work when reviewed at each of the review timepoints listed above, until they answer in the affirmative.
• Return to driving or public transport. [ Time Frame: 10,26,52 weeks. ]
  Time to initial return to driving (or use of public transport if non-driver), measured in days from date of injury. To be reported as the measure of central tendency (mean or median) and standard deviation or interquartile range, for each group (arm of trial). Patients will be asked whether they have returned to these activities when reviewed at each of the review timepoints listed above, until they answer in the affirmative.
• Return to sport. [ Time Frame: 10,26,52 weeks. ]
  Time to initial return to sporting activity (if applicable) measured in days from date of injury. To be reported as the measure of central tendency (mean or median) and standard deviation or interquartile range, for each group (arm of trial). Patients will be asked whether they have returned to sporting activities when reviewed at each of the review timepoints listed above, until they answer in the affirmative.
• Achilles tendon rerupture rate [ Time Frame: 1 year
  
  

  Original Secondary Outcome: Same as current
  
  Information By: NHS Lothian
  

  Dates:
  Date Received: October 15, 2015
  Date Started: November 2013
  Date Completion: November 2018
  Last Updated: November 4, 2015
  Last Verified: November 2015