Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001376831
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
11/10/2021
Date last updated
9/11/2022
Date data sharing statement initially provided
11/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Streamlining Management And Rehabilitation with Technology for ankle fractures:
The (SMART-Ankle) feasibility study
Scientific title
Streamlining Management And Rehabilitation with Technology for ankle fractures: The (SMART-Ankle) feasibility study testing use of a weight bearing monitoring sensor post-surgery
Secondary ID [1] 304776 0
nil known
Universal Trial Number (UTN)
U1111-1268-0473
Trial acronym
SMART-Ankle
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 322836 0
Condition category
Condition code
Musculoskeletal 320418 320418 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 321224 321224 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be fitted with an Aircast boot in theatre immediately following surgery completion. This is standard practice and patients typically wear this Aircast boot for six weeks post surgery, removing it to shower etc.
The Aircast boot fitted to patients who have consented to participate in this study will be fitted with a monitoring sensor which will record weight bearing characteristics, such that a picture emerges on how the patient uses their (operated) leg and how weight bearing changes as the rehabilitation progresses.
Once the patient has provided informed consent to participate in the study they will be provided with the following:
a) An education leaflet detailing care of their fracture and range of exercises at each stage of rehabilitation.
b) Information about the device including instructions on how to charge the device periodically. This information leaflet has been specifically designed and produced by the clinicians at RBWH for this study, and has been approved by HREC.
c) As part of routine clinical care all patients are offered fortnightly follow-up visits with the physiotherapist as well as routine orthopaedic outpatient reviews at 2, 6 and 12 weeks post operatively. At these orthopaedic outpatient reviews the patient will also be asked to complete two questionnaires - the EQ-5D 5L and the AFORM. Completion of these questionnaires will take approximately 10 minutes.
d) Patients who have consented to this study will have the Aircast boot substituted with the Magnes shoe at 6 weeks post operatively if their clinical state allows for the Aircast boot to be removed.
In total, participants will be wearing the Aircast boot for the first six week post operatively, and the Magnes NUSHU shoe for the subsequent six weeks. The duration of the their participation in the study will be 12 weeks.
Intervention code [1] 321157 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328265 0
Feasibility of using the Magnes device in the Aircast boot assessed from semi-structured interview with participants,
Timepoint [1] 328265 0
12 weeks post operatively
Primary outcome [2] 329011 0
Acceptability of Aircast boot with Magnes device and Magnes NUSHU assessed from semi-structured interview with participants (ease of data upload, device charging and monitoring and any other issues relevant to using the device will be explored during interview).
Timepoint [2] 329011 0
12 weeks post operatively
Secondary outcome [1] 398274 0
AFORM Questionnaire assessing ankle function and pain.
Timepoint [1] 398274 0
2 and 6 and 12 weeks post surgery
Secondary outcome [2] 400360 0
Return to Work will be assessed by a semi structured interview.
Timepoint [2] 400360 0
6 and 12 weeks post surgery
Secondary outcome [3] 400361 0
EQ-5D 5L Questionnaire
Timepoint [3] 400361 0
2 and 6 and 12 weeks post surgery
Secondary outcome [4] 401160 0
Range of ankle movement (dorsiflexion/plantarflexion) measured with a goniometer.
Timepoint [4] 401160 0
2, 6 and 12 weeks post operatively
Secondary outcome [5] 401161 0
Consumption of over the counter and prescription analgesics assessed by medication diary
Timepoint [5] 401161 0
Daily diary for 12 weeks
Secondary outcome [6] 401162 0
Clinical measures - x-ray, wound review and complications. Review of these clinical measures is routine care for all patients who have undergone fracture surgery.
Timepoint [6] 401162 0
2, 6 and 12 weeks post operatively.

Eligibility
Key inclusion criteria
• Are 18 years or older at the time of recruitment.
• Have suffered an ankle fracture that can be classified as tibia/fibula, malleolar segment according to the AO Foundation-Orthopaedic Trauma Association (AO-OTA) Fracture and Dislocation Classification Compendium 2018
o infrasyndesmotic fibula injury
o trans-syndesmotic fibula fracture, and
o supra-syndesmotic fibula injury
And, had ankle fracture surgery (fracture types include the fracture types described above and in addition single malleolar, bi-malleolar not extending into the tibial plafond and tri-malleolar with posterior fragment <20%).
• Have a Charlson Comorbidity Index score of 4 or less.
• Can stand and walk with and without crutches when wearing the Aircast boot at the time of data collection.
• Can attend follow-up visits at the RBWH in person.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A Charlson Comorbidity Index score 5 or higher
2. Foot or leg size incompatible with available Magnes shoes or Aircast boot
3. Comorbidities:
a. concurrent or pre-existing injuries that impair the ability to use the orthosis as intended (e.g. neurological conditions including Multiple Sclerosis, brain injury, spinal cord injury);
b. patients with any other disorders involving restriction of mobility, limited ambulation on forearm crutches, or conditions affecting the fracture healing process (e.g. joint disease, neurological disorder, amputation)
c. BMI >35kg/m2
4. Require non-standard postoperative care
5. Not able to attend follow-up visits at the RBWH.
6. Have suffered any of the following fracture types:
a. talus fractures
b. pilon (tibial plafond) fractures
c. calcaneal fractures
d. stress fractures
e. ankle fractures associated with ipsilateral (mid)foot fractures
f. bilateral lower limb fractures
g. concomitant upper limb fractures or injury
h. Posterior malleolus fractures requiring posterior plating
i. small and undisplaced fractures that can be managed non-operatively
j. trimalleolar fractures with significant posterior involvement that are not suitable for early weight-bearing
k. open (compound) fractures or fractures on both lower limbs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
24/01/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
12
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19973 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 23525 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 34680 0
4029 - Herston
Recruitment postcode(s) [2] 34681 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [3] 38938 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 309150 0
Government body
Name [1] 309150 0
Metro North Health Service
Country [1] 309150 0
Australia
Primary sponsor type
Government body
Name
Metro North Health Service
Address
Level 14, Block 7
Butterfield Street
Herston, QLD,
4029
Country
Australia
Secondary sponsor category [1] 310111 0
None
Name [1] 310111 0
Address [1] 310111 0
Country [1] 310111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309015 0
Royal Brisbane and Womens Hospital HREC
Ethics committee address [1] 309015 0
Ethics committee country [1] 309015 0
Australia
Date submitted for ethics approval [1] 309015 0
13/07/2021
Approval date [1] 309015 0
06/08/2021
Ethics approval number [1] 309015 0
HREC/2021/QRBW/70455

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112650 0
Dr Panagiotis Barlas
Address 112650 0
Jamieson Trauma Institute
Level 11, Block 7
Royal Brisbane Womens Hospital
Butterfield Street
Herston 4029
Queensland
Country 112650 0
Australia
Phone 112650 0
+61736461615
Fax 112650 0
Email 112650 0
[email protected]
Contact person for public queries
Name 112651 0
Panagiotis Barlas
Address 112651 0
Jamieson Trauma Institute Level 113 Block 7 Royal Brisbane Womens Hospital Butterfield Street Herston 4029 Queensland
Country 112651 0
Australia
Phone 112651 0
+61736461615
Fax 112651 0
Email 112651 0
[email protected]
Contact person for scientific queries
Name 112652 0
Panagiotis Barlas
Address 112652 0
Jamieson Trauma Institute
Level 11, Block 7
Royal Brisbane Womens Hospital
Butterfield Street
Herston 4029
Queensland
Country 112652 0
Australia
Phone 112652 0
+61736461615
Fax 112652 0
Email 112652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.