Condition category
Musculoskeletal Diseases
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
15/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Rupture of the Achilles tendon (that attaches calf to the heel bone) is a serious and disabling injury. The condition can cause prolonged periods off work and away from sporting activity for much longer. Extended hospital stay and delayed healing have significant financial and health impact for the patient, the NHS and society as a whole. Therefore, it is important to find the best way to treat patients with this injury in order to get them back to their normal activity as quickly as possible. This study aims to find out the best treatment for an Achilles tendon rupture. We are comparing two treatments – one involves a walking boot and one involves a plaster cast, both are standard existing treatments.

Who can participate?
All patients coming with an acute Achilles tendon rupture will be invited to take part in this initial study. A total of 20 patients will be recruited.

What does the study involve?
All patients will be randomly allocated to either the walking boot group or the plaster cast group. The allocation process will be done by a computer and will be done purely by chance. All patients will be asked to fill out a questionnaire about their health and activities. These same questions will be asked on three occasions during the recovery process. The results we get from one treatment group will then be compared with the results we get from the other group.

What are the possible benefits and risks of participating?
This research will inform a UK-wide study to ensure that all patients receive the best treatment in the future. We do not know which of these treatments gives the best results; both treatments are already available and used widely within the NHS.

Where is the study run from?
Warwick Clinical Trials Unit at the University of Warwick, UK.

When is study starting and how long is it expected to run for?
The study will start in November 2013 and is expected to run for two years.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Rebecca Kearney
r.s.kearney@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Kearney

ORCID ID

Contact details

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
-
r.s.kearney@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14105

Study information

Scientific title

Accelerated rehabilitation for patients with a rupture of the Achilles tendon: A mixed-methods approach to evaluating clinical outcomes and cost-effectiveness

Acronym

STAR

Study hypothesis

Eleven thousand patients sustain a torn Achilles tendon each year, yet our knowledge of rehabilitation following this injury is limited. This pilot project will investigate two different methods of rehabilitation: accelerated rehabilitation using a functional bracing protocol versus standard treatment in plaster cast.
To achieve this a national survey of doctors will be undertaken to find out about what current practice is. To design this survey a focus group consisting of approximately ten doctors will be consulted. This will be followed by inviting approximately twelve doctors who have responded to the survey to take part in an interview to gain feedback on their experience of this injury. This will be followed by inviting and interviewing ten patients who present to the University Hospitals of Coventry and Warwickshire with a torn Achilles tendon rupture, to inform the design of a pilot trial comparing the two treatments.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14105

Ethics approval

12/WM/0083

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

1. Plaster cast immobilisation: One treatment group will receive a plaster cast placed in a planter-flexed position, for a duration of eight weeks. During this period patients will be told not to bear weight until the final two weeks.
2. Walking Boot: One treatment group will receive a walking boot, in which the foot will be placed in a plantar-flexed position, for a duration of eight weeks. During this period patients will be told to weight bear immediately and remove the walking boot for short periods during the day to perform ankle range of movement exercises.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Achilles tendon Total Rupture Score - This is a patient reported outcome score containing ten items, for which patients are asked to respond using an 11 point Likert scale to measure the construct of `symptoms and physical activity'.

Secondary outcome measures

1. EQ-5D - A validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 5-level answer possibility. The combination of answers leads to the QoL score.
2. SF12 - The Short-Form 12 is a validated and widely-used health-related quality of life measure
3. Complications - all complications will be recorded
4. Resource use will be monitored for the economic analysis.

Overall trial start date

01/04/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients over 18 years presenting at either the University Hospitals of Coventry and Warwickshire with a primary acute rupture of their Achilles tendon (within 10 days of rupture) would be eligible to take part.
Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Patients presenting after 14 days from injury or with a history of previous Achilles tendon rupture would be excluded.
2. Patients who had other serious injuries to either lower limb that would alter the intervention and subsequent rehabilitation would also be excluded. This is in addition to patients who are unable to adhere to trial procedures, with explicit reasons documented and reported.

Recruitment start date

01/04/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital, Coventry
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

University House
Kirby Corner Road
Coventry
CV4 8DS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Trainees Coordinating Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25868938

Publication citations

Additional files

Editorial Notes