- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598843
Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lothian
-
Edinburgh, Lothian, United Kingdom, EH16 4SA
- Royal Infirmary Edinburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard treatment protocol
Cast immobilisation with 4 weeks in equinus cast (non-weight bearing) followed by 4 weeks in semi-equinus cast (non-weightbearing) and 2 weeks in neutral cast (full weightbearing).
At this point, the cast is removed and patients mobilise fully weightbearing for a further 2 weeks out of cast, with internal shoe insert heel raise.
Commence physiotherapy at 10 weeks, when cast removed.
|
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 |
Experimental: Accelerated rehabilitation
4 weeks in Ossur rebound walking boot with 2 heel wedges (3cm), 2 weeks in Ossur rebound walking boot with 1 heel wedge (1.5cm) and 2 weeks in Ossur rebound walking boot with no heel wedges (neutral position).
Fully weightbearing throughout.
Commence physiotherapy at 8 weeks.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SMFA (Short Musculoskeletal Function Assessment Questionnaire)
Time Frame: final followup/one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 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.
|
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.
|
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.
|
1 year
|
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.
|
10, 26 and 52 weeks
|
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..
|
10, 26 and 52 weeks
|
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.
|
Initial review, 4,8,10,26,52 weeks.
|
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) 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.
|
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.
|
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
|
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.
|
10,26,52 weeks.
|
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.
|
10,26,52 weeks.
|
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.
|
10,26,52 weeks.
|
Achilles tendon rerupture rate
Time Frame: 1 year
|
Number of achilles tendon re-ruptures occuring in each group up to one year after injury.
|
1 year
|
EQ-5D Index and EQ-5D VAS
Time Frame: Pre-injury and post-injury (completed at initial review), 26 weeks and 52 weeks
|
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
|
Satisfaction Question
Time Frame: 10, 16, 26 and 52 weeks
|
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
|
Patient Preference question
Time Frame: 16 weeks
|
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
|
Achilles Tendon Total Rupture Score (ATRS)
Time Frame: Post-injury (completed at initial review)
|
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)
|
SMFA (Short Musculoskeletal Function Assessment Questionnaire)
Time Frame: Post-injury (completed at initial review)
|
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)
|
Foot and Ankle Outcomes Questionnaire
Time Frame: Post-injury (completed at initial review)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leela Biant, BSc (Hons) MBBS FRSCEd MSres, University of Manchester
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS ID 89061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rupture of Achilles Tendon
-
Peking University Third HospitalCompletedAchilles Tendon Rupture | Avulsion Fracture of the Achilles Tendon
-
Aristotle University Of ThessalonikiGeneral Hospital of Naoussa; Private Orthopedics Practice P. SymeonidisEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon Injury | Achilles Tendon SurgeryGreece
-
Henry Ford Health SystemRecruitingAchilles Tendon Rupture | Achilles Tendon SurgeryUnited States
-
University Hospital, AkershusVestre Viken Hospital Trust; Oslo University Hospital; Sykehuset Ostfold; Hjelp24Completed
-
Aarhus University HospitalEnrolling by invitationAchilles Tendon Rupture | Achilles Tendon InjuryDenmark
-
Peking University Third HospitalCompletedAcute Rupture of Achilles Tendon (Disorder)China
-
Tanta UniversityCompletedAcute Rupture of Achilles Tendon
-
Centre Hospitalier Universitaire DijonCompletedAcute Unilateral Rupture of the Achilles TendonFrance
-
Chinese University of Hong KongNot yet recruitingAchilles Tendinopathy | Achilles Tendon RuptureHong Kong
-
Penn State UniversityRecruiting
Clinical Trials on Standard treatment protocol
-
Chang Gung Memorial HospitalNot yet recruitingHodgkin Lymphoma | Non Hodgkin Lymphoma | Mediastinal LymphomaTaiwan
-
Chang Gung Memorial HospitalRecruiting
-
Universidad San JorgeMontpellier ClinicCompletedSubacromial ImpingementSpain
-
Instituto Politécnico de LeiriaUniversidade Católica PortuguesaCompleted
-
Harran UniversityCompletedDiabetic Foot Ulcer | WoundTurkey
-
Hospital de Santa Maria, PortugalInstituto Politécnico de LeiriaCompleted
-
University Hospital, BordeauxInstitut National de la Santé Et de la Recherche Médicale, France; Université... and other collaboratorsCompletedAlzheimer's DiseaseFrance
-
Sehat Medical ComplexCompletedStroke, Anterior Cerebral ArteryPakistan
-
Thais Amanda RodriguesCompleted
-
Canadian Scleroderma Research GroupCanadian Institutes of Health Research (CIHR)UnknownSystemic Sclerosis | Small Intestinal Bacterial OvergrowthUnited States, Australia