UK Study of tendo Achilles Rehabilitation
| ISRCTN | ISRCTN62639639 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62639639 |
| Secondary identifying numbers | HTA 13/115/62; v1.0 |
- Submission date
- 09/06/2015
- Registration date
- 22/06/2015
- Last edited
- 10/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Current plain English summary as of 01/08/2018:
Background and study aims
The Achilles tendon is the largest tendon in the human body and transmits the powerful contractions of the calf muscles that are required for walking and running. Consequently, when the tendon ruptures it has a serious detrimental impact on daily activities and results in prolonged periods off work and away from sporting activity. Achilles tendon rupture affects over 11,000 people each year in the UK, and the incidence is increasing as the population remains more active into older age. Controversy remains with regards the best rehabilitation plan for patients with a rupture of the Achilles. Traditionally, patients have been treated in a series of plaster casts; the casts extend from below the knee and around the ankle. The position of the cast is changed until the patient can put their weight through the foot. However, there is some evidence that a functional brace or ‘walking boot’ gives as much support and may speed recovery in the first year after the injury. We therefore propose to perform a study comparing plaster casts with functional bracing for patients with a rupture of the Achilles tendon. Phase 1 will confirm how many patients are willing to take part in a large-scale multi-centre randomised controlled trial. Phase 2 will be the proposed randomised controlled trial in a minimum of 22 hospitals across the UK.
Who can participate?
Adult patients attending a trial centre with a rupture of the Achilles tendon who have decided not to have surgery.
What does the study involve?
Patients will be randomly allocated to be treated with either functional bracing or a plaster cast. Both plaster casts and functional braces are widely used within the NHS, for both broken bones and sprains, and all of the clinical teams in the trial centres will be familiar with both techniques. A researcher will perform a clinical assessment and make a record of any early complications at 8 weeks. Functional outcome, quality of life and questionnaires of out-of-pocket expenses will be collected at 3, 6 and 9 months post-injury.
What are the possible benefits and risks of participating?
There are no specific risks or benefits to participants as both interventions are already used widely in the treatment of patients with an Achilles tendon rupture. The risks of an Achilles tendon rupture include: re-rupture, tendon lengthening, calf muscle weakness and blood clots, and these risks are present for both groups of patients in the study and indeed all patients with this injury.
Where is the study run from?
Oxford University Hospitals NHS Trust (UK).
When is the study starting and how long is it expected to run for?
April 2016 to May 2019
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).
Who is the main contact?
Dr Susan Wagland
UKSTAR@ndorms.ox.ac.uk
Previous plain English summary:
Background and study aims
The Achilles tendon is the largest tendon in the human body and transmits the powerful contractions of the calf muscles that are required for walking and running. Consequently, when the tendon ruptures it has a serious detrimental impact on daily activities and results in prolonged periods off work and away from sporting activity. Achilles tendon rupture affects over 11,000 people each year in the UK, and the incidence is increasing as the population remains more active into older age. Controversy remains with regards the best rehabilitation plan for patients with a rupture of the Achilles. Traditionally, patients have been treated in a series of plaster casts; the casts extend from below the knee and around the ankle. The position of the cast is changed until the patient can put their weight through the foot. However, there is some evidence that a functional brace or ‘walking boot’ gives as much support and may speed recovery in the first year after the injury. We therefore propose to perform a study comparing plaster casts with functional bracing for patients with a rupture of the Achilles tendon. Phase 1 will confirm how many patients are willing to take part in a large-scale multi-centre randomised controlled trial. Phase 2 will be the proposed randomised controlled trial in a minimum of 22 hospitals across the UK.
Who can participate?
Adult patients attending a trial centre with a rupture of the Achilles tendon who have decided not to have surgery.
What does the study involve?
Patients will be randomly allocated to be treated with either functional bracing or a plaster cast. Both plaster casts and functional braces are widely used within the NHS, for both broken bones and sprains, and all of the clinical teams in the trial centres will be familiar with both techniques. A researcher will perform a clinical assessment and make a record of any early complications at 8 weeks. Functional outcome, quality of life and questionnaires of out-of-pocket expenses will be collected at 3, 6 and 9 months post-injury.
What are the possible benefits and risks of participating?
There are no specific risks or benefits to participants as both interventions are already used widely in the treatment of patients with an Achilles tendon rupture. The risks of an Achilles tendon rupture include: re-rupture, tendon lengthening, calf muscle weakness and blood clots, and these risks are present for both groups of patients in the study and indeed all patients with this injury.
Where is the study run from?
Oxford University Hospitals NHS Trust (UK).
When is the study starting and how long is it expected to run for?
April 2016 to May 2019
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).
Who is the main contact?
Dr Susan Wagland
UKSTAR@ndorms.ox.ac.uk
Contact information
Scientific
Nuffield Department Of Orthopaedics, Rheumatology and Muscoloskeletal Sciences
University of Oxford
Oxford
OX3 7HE
United Kingdom
| Phone | +44 (0)1865 223115 |
|---|---|
| ukstar@ndorms.ox.ac.uk |
Study information
| Study design | Multi-centre two-arm parallel-group assessor-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | UK Study of tendo Achilles Rehabilitation – a multicentre randomised clinical trial |
| Study acronym | UK STAR |
| Study hypothesis | There is no difference in the Achilles Tendon Rupture Score 9 months after rupture of the Achilles tendon, in non-operatively treated adult patients with either functional bracing or plaster cast immobilisation. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1311562 |
| Ethics approval(s) | South Central - Oxford B Research Ethics Committee, 18/03/2016, REC ref: 16/SC/0109 |
| Condition | Achilles tendon rupture |
| Intervention | Participants will be randomized 1:1 to the following two groups: 1. A plaster cast will be applied in the ‘gravity equinus’ position. Over the first 8 weeks, as the tendon heals, the position of the plaster cast is changed until the foot achieves ‘plantargrade’. Weight bearing can commence thereafter. 2. A rigid functional brace will be applied, with equines foot position initially. Weight bearing can commence immediately. Plantargrade will be achieved gradually over 8 weeks after which the brace will be removed. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | The primary outcome measure for this study is the Achilles tendon Total Rupture Score (ATRS). The ATRS is a validated questionnaire which is self-reported (filled out by the patient). It consists of 10 items assessing symptoms and physical activity specifically related to the Achilles tendon. It measures: strength, fatigue, stiffness, pain, activities of daily living, walking on uneven surfaces, walking upstairs or uphill, running, jumping and physical labour. This data will be collected at baseline, 3, 6 and 9 months post-injury. |
| Secondary outcome measures | 1. EQ-5D; The EQ-5D-5L is a validated, generic health-related quality of life measure consisting of 5 dimensions each with a 5-level answer possibility. 2. Complications; all complications will be recorded, from the medical records at the 8-week review and self-reported by the patient thereafter, including: re-rupture, blood clots/emboli, pressure areas/hindfoot pain, falls and neurological symptoms in the foot. |
| Overall study start date | 01/04/2016 |
| Overall study end date | 31/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Minimum 330, Maximum 550 |
| Total final enrolment | 540 |
| Participant inclusion criteria | Patients will be considered for participation in this study if: 1. They are aged 16 years or older 2. They have a primary rupture of the Achilles tendon 3. They have decided to have non-operative treatment |
| Participant exclusion criteria | Patients will be excluded from participation in this study if they: 1. Present to the treating hospital more than 14 days after the injury 2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires; for example, a history of permanent cognitive impairment |
| Recruitment start date | 01/07/2016 |
| Recruitment end date | 31/05/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 9DU
United Kingdom
Sponsor information
University/education
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Matt Costa (matthew.costa@ndorms.ox.ac.uk). 1. Type of data that will be shared: individually assessed on request for data sharing 2. When the data will become available and for how long: individually assessed on request for data sharing 3. By what access criteria data will be shared including with whom: individually assessed on request for data sharing 4. For what types of analyses: individually assessed on request for data sharing 5. By what mechanism: individually assessed on request for data sharing 6. Whether consent from participants was obtained: no 7. Comments on data anonymization: all data will be de-identified 8. Any ethical or legal restrictions: individually assessed on request for data sharing 9. Any other comments: none |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/10/2017 | 03/06/2019 | Yes | No |
| Statistical Analysis Plan | statistical analysis plan: | 30/05/2019 | 03/06/2019 | No | No |
| Results article | results | 08/02/2020 | 10/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/02/2020 | 10/07/2023 | Yes | No |
Editorial Notes
10/07/2023: Publication reference added.
18/02/2021: IPD sharing statement added.
16/02/2021: Internal review.
10/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
03/06/2019: Publication reference added.
01/08/2018: The following changes were made to the trial record:
1. Contact details updated.
2. The plain English summary has been updated
3. The total target enrolment was changed from 550 to 541
31/10/2017: The target number of participants has been updated from 330 to 550. The minimum target number of participants is 330 and the maximum is 550.
On 06/04/2016 the following changes were made to the trial record:
1. The overall trial start date was changed from 01/01/2016 to 01/04/2016.
2. The overall trial end date was changed from 28/02/2019 to 31/05/2019.
3. The recruitment start date was changed from 01/04/2016 to 01/07/2016.
4. The recruitment end date was changed from 28/02/2018 to 31/05/2018.
