Clinical trial NCT02598843: Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Achilles Tendon
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2015-11-06
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SMFA (Short Musculoskeletal Function Assessment Questionnaire)
timeFrame: final followup/one year
Secondary outcomes:
measure: SMFA (Short Musculoskeletal Function Assessment Questionnaire)
timeFrame: 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.
measure: Incidence of thromboembolic events
timeFrame: 1 year
measure: Ankle and subtalar motion
timeFrame: 10, 26 and 52 weeks
measure: Calf circumference
timeFrame: 10, 26 and 52 weeks
measure: Visual Analogue Score (VAS) for pain
timeFrame: Initial review, 4,8,10,26,52 weeks.
measure: Foot and Ankle Outcomes Questionnaire
timeFrame: 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.
measure: Achilles Tendon Total Rupture Score (ATRS)
timeFrame: 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
measure: Return to work.
timeFrame: 10,26,52 weeks.
measure: Return to driving or public transport.
timeFrame: 10,26,52 weeks.
measure: Return to sport.
timeFrame: 10,26,52 weeks.
measure: Achilles tendon rerupture rate
timeFrame: 1 year
measure: EQ-5D Index and EQ-5D VAS
timeFrame: Pre-injury and post-injury (completed at initial review), 26 weeks and 52 weeks
measure: Satisfaction Question
timeFrame: 10, 16, 26 and 52 weeks
measure: Patient Preference question
timeFrame: 16 weeks
measure: Achilles Tendon Total Rupture Score (ATRS)
timeFrame: Post-injury (completed at initial review)
measure: SMFA (Short Musculoskeletal Function Assessment Questionnaire)
timeFrame: Post-injury (completed at initial review)
measure: Foot and Ankle Outcomes Questionnaire
timeFrame: Post-injury (completed at initial review)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary Edinburgh
state: Lothian
Study officials:
affiliation: University of Manchester
name: Leela Biant, BSc (Hons) MBBS FRSCEd MSres
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maempel JF, Clement ND, Duckworth AD, Keenan OJF, White TO, Biant LC. A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures. Am J Sports Med. 2020 Sep;48(11):2755-2764. doi: 10.1177/0363546520944905. Epub 2020 Aug 20.