Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures

Rupture of Achilles Tendon Clinical Trial

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 Accelerated Rehabilitation Using a Moon Boot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598843
• Other study ID #: IRAS ID 89061
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 3, 2019

Study information

• Verified date: January 2020
• Source: NHS Lothian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients aged 16-60 years old with an acute rupture of the Achilles tendon

Exclusion Criteria:

• Patients who do not have an acute rupture (ie. delayed presentation >2 weeks)

• Patients who present with a re-rupture of a previously treated Achilles tendon

• Patients from outside the Lothian (local treatment) area who are unwilling to attend follow-up at the study institution.

• Latex allergy.

Related Conditions & MeSH terms

• Rupture
• Rupture of Achilles Tendon

Intervention

Other:
• Standard treatment protocol
Cast Protocol 4 weeks in Full Equinus cast - Non Weight Bearing (NWB) with axillary crutches; 4 weeks in Semi-Equinus cast NWB with axillary crutches; 2 weeks in neutral cast - Full Weight Bearing (FWB); 2 weeks FWB out of cast, with shoe insert heel raise. Followed by course of physiotherapy
• Accelerated Rehabilitation
4 weeks in Ossur Rebound walking boot with 3cm heel raise, worn continuously including in bed. Weight bearing as tolerated (WBAT)/FWB - crutches for balance; 2 weeks in Rebound walking boot with 1.5cm heel raise (WBAT/FWB - crutches for balance; 2 weeks in Rebound walking boot with foot in neutral. At 8 weeks, remove boot and allow FWB out of boot. At 8 weeks after initiation of treatment, physiotherapy is commenced.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary Edinburgh	Edinburgh	Lothian

Sponsors (1)

Lead Sponsor	Collaborator
NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMFA (Short Musculoskeletal Function Assessment Questionnaire)	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.	final followup/one year
Secondary	SMFA (Short Musculoskeletal Function Assessment Questionnaire)	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.	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 weeks.
Secondary	Incidence of thromboembolic events	Incidence of radiologically confirmed thromboembolic events within one year of injury is to be reported for each group.	1 year
Secondary	Ankle and subtalar motion	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.	10, 26 and 52 weeks
Secondary	Calf circumference	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..	10, 26 and 52 weeks
Secondary	Visual Analogue Score (VAS) for pain	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.	Initial review, 4,8,10,26,52 weeks.
Secondary	Foot and Ankle Outcomes Questionnaire	American Academy of Orthopaedic Surgeons (AAOS) 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.	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.
Secondary	Achilles Tendon Total Rupture Score (ATRS)	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.	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
Secondary	Return to work.	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.	10,26,52 weeks.
Secondary	Return to driving or public transport.	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.	10,26,52 weeks.
Secondary	Return to sport.	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.	10,26,52 weeks.
Secondary	Achilles tendon rerupture rate	Number of achilles tendon re-ruptures occuring in each group up to one year after injury.	1 year
Secondary	EQ-5D Index and EQ-5D VAS	The EQ-5D-5L consists of an EQ-5D index, calculated from scores for 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the index ranges from -1 to +1. The EQ-5D visual analog scale (VAS) asks patients to self-rate their health state on a scale between 0 and 100. Data to be analysed and presented as measure of central tendency (median/mean) and standard deviations/interquartile ranges for patients in each group. This data is collected for the final 41 patients in this study.	Pre-injury and post-injury (completed at initial review), 26 weeks and 52 weeks
Secondary	Satisfaction Question	Patients asked "How satisfied are you with your treated ankle?". They must choose one of "Very satisfied"/"satisfied"/"neither satisfied nor dissatisfied"/"dissatisfied"/"very dissatisfied". Responses to be analysed as dichotomous data and ordinal data. This data is collected for the final 41 patients in this study.	10, 16, 26 and 52 weeks
Secondary	Patient Preference question	Patients asked "Did you have a preference for treatment type for your Achilles tendon injury?" (Choose one of: YES / NO). If Yes, then which modality would you have preferred? (choose one of CAST / BOOT ). Data will be cross tabulated for statistical analysis. This data is collected for the final 41 patients in this study.	16 weeks
Secondary	Achilles Tendon Total Rupture Score (ATRS)	As above. An additional time point (post-injury), to be completed at the initial review, was added for the final 41 patients in this study.	Post-injury (completed at initial review)
Secondary	SMFA (Short Musculoskeletal Function Assessment Questionnaire)	As above. An additional time point (post-injury), to be completed at the initial review, was added for the final 41 patients in this study.	Post-injury (completed at initial review)
Secondary	Foot and Ankle Outcomes Questionnaire	As above. An additional time point (post-injury), to be completed at the initial review, was added for the final 41 patients in this study.	Post-injury (completed at initial review)