Post-operative bracing following repair of the Achilles tendon
| ISRCTN | ISRCTN12135226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12135226 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 295136 |
| Protocol serial number | IRAS 295136 |
| Sponsor | Shrewsbury and Telford Hospital NHS Trust |
| Funder | Investigator initiated and funded |
- Submission date
- 14/10/2021
- Registration date
- 03/11/2021
- Last edited
- 22/10/2021
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims:
An Achilles tendon rupture is a tear of the tendon that connects the calf muscles to the heel bone. Following an Achilles tendon rupture it is routine to protect patients in a cast or a brace to allow them to move around or mobilise. Mobilising is good, encourages the tendon to heal and avoids complications like blood clots in the calf veins. A previous method used a front shell with patients putting weight on the balls of their feet and not loading on the heel area of the foot at all for 6 weeks. Patients managed using this method did well, reporting good outcome scores and functional tasks on assessment. Their tendons did however lengthen slightly and if they had a fall or a stumble, and put too much weight onto the injured leg to stop their fall, could re-rupture their tendons.
Most treatments use a protective brace for at least 8 weeks and many provide support underneath the midfoot and heel such as a boot with wedges. The aim of this study is to compare the outcome of patients following minimally-invasive Achilles tendon repair mobilising for 6 weeks of weight-bearing in an anterior shell with those mobilising for 8 weeks in an anterior shell and heel wedges.
Who can participate?
Patients aged 18-65 years with an acute Achilles tendon rupture who underwent surgery
What does the study involve?
The aim is to study a group of patients who had received a similar repair of their Achilles tendon in terms of suture material and repair technique, but received a longer period of protection for 8 weeks. From 2-8 weeks following repair patients are allowed to mobilise, with the assistance of crutches, in a walker boot with wedges under the midfoot and heel in addition to the anterior cast shell.
Participating in the study involves nothing other than reading the patient information leaflet, agreeing to take part in the study and signing the consent form. The patient’s management and evaluation would actually be routine patient management with nothing additional.
What are the possible benefits and risks of participating?
The only benefit in taking part is the knowledge that patients may be contributing to science. There is a theoretical risk of taking part in that tendons might heal tighter but this does not appear to be the case from previous studies, with tendon lengthening being the main problem.
Where is the study run from?
Shrewsbury & Telford Hospital NHS Trust (UK)
When is the study starting and how long is it expected to run for?
May 2021 to May 2028
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Mike Carmont
m.carmont@nhs.net
Contact information
Scientific
Princess Royal Hospital
Telford
TF1 6TF
United Kingdom
| Phone | +44 (0)1952 641222 ext 4381 |
|---|---|
| m.carmont@nhs.net |
Public
Royal Shrewsbury Hospital
Shrewsbury
SY3 8XQ
United Kingdom
| Phone | +44 (0)1743 261000 ext 1646 |
|---|---|
| kellyhard@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomized cohort comparison study |
| Secondary study design | Cohort study |
| Participant information sheet | 40547 _PIS_27Apr21_V3.doc |
| Scientific title | Comparison of methods and duration of post-operative bracing following repair of acute Achilles tendon rupture |
| Study acronym | POBRAT |
| Study objectives | The aim of this study is to compare the outcome of patients following minimally-invasive Achilles tendon repair mobilising for 6 weeks of weight-bearing in an anterior shell with those mobilising for 8 weeks in an anterior shell and heel wedges. |
| Ethics approval(s) | Approved 06/04/2021, South Central - Oxford C Research Ethics Committee (Health Research Authority (Bristol), Ground Floor, Temple Quay House, 2 The Square, BS1 6PN, UK; +44 (0)207 104 8379; oxfordc.rec@hra.nhs.uk), REC ref: 07/MRE08/9 |
| Health condition(s) or problem(s) studied | Post-operative bracing following repair of the Achilles tendon |
| Intervention | Contemporaneous data collection is performed at routine follow up at the completion of brace use at 6 and 8 weeks, and at 3, 6, 9 and 12 months following repair. The primary outcome measure is the Heel-Rise Height Index (HRHI), comparing maximal sustained heel-rise of the injured side to the non-injured side at 12 months following repair. The HRHI is an indirect measure of tendon elongation. Secondary outcome measures include the ATRA, a validated direct measure of tendon length, the Achilles tendon Total Rupture Score (ATRS), a patient-reported outcome measure, the Tegner Score, and the Patient Perception of Performance. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Tendon elongation measured using the Heel-Rise Height Index (HRHI), comparing maximal the sustained heel-rise of the injured side to the non-injured side at 12 months following repair |
| Key secondary outcome measure(s) |
Measured at 3, 6, 9 and 12 months following repair: |
| Completion date | 31/05/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Mid-substance Achilles tendon rupture, diagnosed clinically by the presence of a palpable gap to the Achilles tendon, and increased Achilles Tendon Resting Angle and a calf squeeze test 2. Aged 18-65 years 3. Presenting <15 days following rupture 4. Able to understand the spoken and written English language 5. After consultation wishes to have operative repair of the Achilles tendon rather than non-operative management 6. Available for 12 months follow up at Shrewsbury and Telford Hospital NHS Trust |
| Key exclusion criteria | 1. Distal Achilles tendon rupture, identified by palpation of the distal stump ending <2 cm proximal to the Achilles insertion 2. Musculotendinous Achilles tendon ruptures, diagnosed by tenderness at the musculotendinous junction and on ultrasonography. Ultrasonography will be used for the confirmation of musculotendinous rupture rather than midsubstance rupture 3. Patients with diabetes mellitus, chronic inflammatory conditions, and musculoskeletal conditions preventing a single heel-rise prior to rupture 4. A previous ipsilateral or contralateral Achilles tendon rupture 5. Patients >110 kg and BMI >30 kg/m² owing to obesity giving an increased risk of wound, cast and functional brace complications |
| Date of first enrolment | 31/05/2027 |
| Date of final enrolment | 01/01/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Mike Carmont (m.carmont@nhs.net). Data will be anonymised before sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 27/04/2021 | 21/10/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 4 | 28/03/2021 | 21/10/2021 | No | No |
Additional files
- 40547 _PROTOCOL_28Mar21_V4.pdf
- Protocol file
- 40547 _PIS_27Apr21_V3.doc
- Participant information sheet
Editorial Notes
21/10/2021: Trial's existence confirmed by South Central - Oxford C Research Ethics Committee.
