Rupture of Achilles TendonNCT02598843
Standard Non Operative Treatment Versus Accelerated Rehabilitation of Achilles Tendon Ruptures
A study testing Standard treatment protocol and Accelerated Rehabilitation in people with Rupture of Achilles Tendon, run by NHS Lothian at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Rupture of Achilles Tendon
- What is being tested?
- Standard treatment protocol and Accelerated Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to 3 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 16-60 years old with an acute rupture of the Achilles tendon
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
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
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.
Read the 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.
- Conditions
- Rupture of Achilles Tendon
- Being tested
- Standard treatment protocol, Accelerated Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment protocolOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment protocol | Active comparator | 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. Receives: Other: Standard treatment protocol |
| Accelerated rehabilitation | Experimental | 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. Receives: Other: Accelerated Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: final followup/one year
Secondary outcomes (17)
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.
Measured: 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
Incidence of radiologically confirmed thromboembolic events within one year of injury is to be reported for each group.
Measured: 1 year
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.
Measured: 10, 26 and 52 weeks
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..
Measured: 10, 26 and 52 weeks
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.
Measured: Initial review, 4,8,10,26,52 weeks.
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.
Measured: 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)
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.
Measured: 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 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.
Measured: 10,26,52 weeks.
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.
Measured: 10,26,52 weeks.
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.
Measured: 10,26,52 weeks.
Achilles tendon rerupture rate
Number of achilles tendon re-ruptures occuring in each group up to one year after injury.
Measured: 1 year
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.
Measured: Pre-injury and post-injury (completed at initial review), 26 weeks and 52 weeks
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.
Measured: 10, 16, 26 and 52 weeks
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.
Measured: 16 weeks
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.
Measured: Post-injury (completed at initial review)
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.
Measured: Post-injury (completed at initial review)
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.
Measured: Post-injury (completed at initial review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2013
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Achilles TendonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Leela Biant, BSc (Hons) MBBS FRSCEd MSres, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598843
- Sponsor's protocol ID
- IRAS ID 89061
- Status last verified
- Jan 2020
- First submitted
- 15 Oct 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32816521
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02598843
- Acronym / sponsor ID
- IRAS ID 89061
- Conditions
- Rupture of Achilles Tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- Nov 2013 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment protocol | Active comparator | Other: Standard treatment protocolCast 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. |
| Accelerated rehabilitation | Experimental | Other: Accelerated Rehabilitation4 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 16-60 years old with an acute rupture of the Achilles tendon
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment protocolCast 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 | Other | Standard treatment protocol |
| Accelerated Rehabilitation4 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. | Other | Accelerated rehabilitation |
Primary outcome
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.
17 secondary outcomes
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.
Incidence of thromboembolic events
Time frame: 1 year
Ankle and subtalar motion
Time frame: 10, 26 and 52 weeks
Calf circumference
Time frame: 10, 26 and 52 weeks
Visual Analogue Score (VAS) for pain
Time frame: 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.
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
Return to work.
Time frame: 10,26,52 weeks.
Return to driving or public transport.
Time frame: 10,26,52 weeks.
Return to sport.
Time frame: 10,26,52 weeks.
Achilles tendon rerupture rate
Time frame: 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
Satisfaction Question
Time frame: 10, 16, 26 and 52 weeks
Patient Preference question
Time frame: 16 weeks
Achilles Tendon Total Rupture Score (ATRS)
Time frame: Post-injury (completed at initial review)
SMFA (Short Musculoskeletal Function Assessment Questionnaire)
Time frame: Post-injury (completed at initial review)
Foot and Ankle Outcomes Questionnaire
Time frame: Post-injury (completed at initial review)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 32816521Maempel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leela Biant, BSc (Hons) MBBS FRSCEd MSres principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment protocol and Accelerated Rehabilitation in people with Rupture of Achilles Tendon, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMFA (Short Musculoskeletal Function Assessment Questionnaire) (time frame: final followup/one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.