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Trial registered on ANZCTR


Registration number
ACTRN12617001588381
Ethics application status
Approved
Date submitted
7/11/2017
Date registered
28/11/2017
Date last updated
6/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transarticular tibio-talo-calcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: a multi-centre, prospective, randomised controlled trial.
Scientific title
Transarticular tibio-talo-calcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: a multi-centre, prospective, randomised controlled trial.
Secondary ID [1] 293057 0
none
Universal Trial Number (UTN)
U1111-1203-1704
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 304984 0
Condition category
Condition code
Surgery 304307 304307 0 0
Surgical techniques
Musculoskeletal 304735 304735 0 0
Other muscular and skeletal disorders
Injuries and Accidents 304736 304736 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Transarticular Tibio-talo-calcaneal (TTC) nailing

TTC nailing will be performed using the Styker T2 Ankle Arthrodesis Nail. The patient’s foot is positioned in neutral dorso-plantar flexion, five to ten degrees of external rotation and 5 degrees of hindfoot valgus. Closed reduction of the fracture is performed under image intensifier (ii) guidance. The longitudinal axis of the calcaneus and tibia are marked on the patient using a Kirschner wire (K-wire) and a marking pen. A 2-3 cm longitudinal incision is made at the intersection of the marked lines, followed by soft tissue dissection to gain access to the plantar aspect of the calcaneus. A K-wire is then inserted through the incision, and after confirmation of positioning with ii is progressed through the calcaneus, across the subtalar and talocrural joints and into the tibial medullary canal. A rigid reamer is used over the wire and reamed until it reaches the medullary canal of the tibia.

A ball-tipped guide is then passed into the tibia with sequential reaming over the wire to 1-1.5mm greater than the nail diameter previously selected. The nail is then locked with two screws proximally through the tibial shaft, and two distally in the calcaneus in orthogonal planes. Skin will be closed with 3.0 nylon interrupted sutures. Patients will be placed in a cam walker and allowed to full weight bear day one post-operatively.

All operations are to be performed by consultant orthopaedic surgeons or their trainees under direct supervision. Patients are positioned supine on a radiolucent table with a sandbag under the ipsilateral hip. All patients will receive intravenous antibiotics. A tourniquet will be used for all operations..
Operations approximate 60-120min in duration.
Intervention code [1] 299297 0
Treatment: Surgery
Intervention code [2] 299618 0
Treatment: Devices
Comparator / control treatment
Open reduction and internal fixation (ORIF).

ORIF will be performed using AO principles via a medial and lateral approach. Fibular fixation will be performed using either 1/3 tubular plate with 3.5mm screws, or locking plates as per surgical consultant preference. Medial malleolus fixation and posterior malleolus fracture fixation, if required, will be carried out. Closure of the wounds will be in layers with 2.0 vicryl to deeper layers, and 3.0 nylon interrupted sutures to skin. A below knee plaster backslab will be applied.

All operations are to be performed by consultants or their trainees under direct supervision. Patients are positioned supine on a radiolucent table with a sandbag under the ipsilateral hip. All patients will receive intravenous antibiotics. A tourniquet will be used for all operations.
Operations approximate 60-120min in duration.
Control group
Active

Outcomes
Primary outcome [1] 303573 0
The primary outcome measure will be overall complication rate, which will be a composite score of the following:
• Superficial wound infection
• Deep surgical infection
• Wound dehiscence
• Failure of metalwork
• Iatrogenic fracture
• Peri-prosthetic fracture
• Rate of secondary interventions
Timepoint [1] 303573 0
Each component will be assessed at the following timepoints: Time of operation 2 and 6 weeks post-operatively 3, 6, 12 and 24 months post-operatively The primary time-point is 24 months post-operatively for the composite outcome score. Definitions of composite components is described below: a. Superficial wound infection - infection superficial to fascia. In cases where operative intervention is not required, superficial infection will be defined according to MSIS (musculoskeletal infection society) criteria b. Deep surgical infection - infection deep to deep fascia. Prosthetic joint infection is defined as per MSIS (musculoskeletal infection society) criteria c. Wound dehiscence - dehiscence of wound at 2 or 6 week review. d. Failure of metalwork - surgical complication directly related to failure of prosthetic implant. This includes screw backout/breaking or bending of metalwork. e. Iatrogenic fracture - defined as fracture caused by operating surgeon during procedure. Will be reviewed at time of operation. Subtle fractures will be noted on day 1 post op x-ray. f. Peri-prosthetic fracture - defined via Vancouver classification system. g. Rate of secondary interventions - defined as repeat operations required for infection, implant failure, metalwork failure, to relieve pain or improve function will be recorded from medical records and reviewed at all time-points. Primary end point 24 months post-operatively.
Secondary outcome [1] 339438 0
Acute hospital length of stay
Timepoint [1] 339438 0
Assessed at time of discharge from acute surgical ward
Secondary outcome [2] 339440 0
Total hospital length of stay.
Timepoint [2] 339440 0
Includes time in hospital if requiring transfer to a rehabilitation facility.
Assessed at time of discharge from hospital.
Secondary outcome [3] 339442 0
Mobility at discharge.
Defined as:
1. Independent with no additional assistance
2. Single point stick/walking stick
3. Crutches
4. Four-wheeled walker
5. Hopper frame
6. wheelchair bound
Timepoint [3] 339442 0
Assessed at time of participant discharge from hospital
Secondary outcome [4] 339444 0
Discharge destination.
Defined as: participant’s normal residence, supported accommodation, rehabilitation facility or nursing home.
Timepoint [4] 339444 0
Assessed at time of discharge
Secondary outcome [5] 339451 0
Number of post-operative transfusions.
Assessed via documentation in participants medical chart
Timepoint [5] 339451 0
Assessed at time of discharge from hospital
Secondary outcome [6] 339452 0
Foot and ankle function via the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Timepoint [6] 339452 0
Assessed at at 3, 6, 12 and 24 months post-operatively
Secondary outcome [7] 339453 0
Foot and ankle function via the Olerud-Molander Ankle Score (OMAS).
Timepoint [7] 339453 0
Assessed at 3, 6, 12 and 24 months post-operatively.
Secondary outcome [8] 339454 0
Rate of secondary interventions.
Secondary intervention is defined as procedure requiring regional or general anaesthesia and is required due to complication arising from original intervention.
Timepoint [8] 339454 0
Assessed at the following timepoints:
2 and 6 weeks post-operatively
3, 6, 12 and 24 months post-operatively
Secondary outcome [9] 339455 0
Mortality rate.
Will be determined from consulting with the Australian Department of Births, Deaths and Marriages.
Timepoint [9] 339455 0
Intra-hospital participant death will be doumented in patient charts.
Participants lost to follow up will have their name checked against the Australian department of Births, Deaths and Marriages at conclusion of the study (24 months post-operatively).
Secondary outcome [10] 339456 0
Quality of life assessed via the EuroQol 5 Dimensions (EQ5D) Quality of life outcome measure.
Timepoint [10] 339456 0
The EQ-5D-3L will be administered pre-operatively, and at three, six and 12 months post-operatively.
Secondary outcome [11] 339457 0
Non-union. Defined as fracture failing to unite in 3 of 4 cortices at 6 months post-operative x-ray.
Timepoint [11] 339457 0
6 months post operative
Secondary outcome [12] 351570 0
Medical Complications. All medical complications will be recorded, including deep vein thrombosis (DVT) and pulmonary embolus (PE). This will be recorded at
Timepoint [12] 351570 0
Discharge and 2, and 6 weeks post-operatively

Eligibility
Key inclusion criteria
• Isolated, displaced, closed ankle fracture
• Age greater than or equal to 50
• Charlson morbidity index greater than or equal to four
• Unstable fracture or fracture dislocation determined by treating team to require operative intervention
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Peri-prosthetic fractures
• Open fractures
• Patient medically not fit for surgery
• Requirement of removal of previous metalwork
• Cognitive impairment limiting ability to give informed consent
• Significant language barrier limiting ability to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals consenting to participate in the trial will be randomized to surgery either by TTC or by conventional ORIF. A 24-hour randomisation service will be provided by Sealed EnvelopeTM. The sequence will be stratified by study centre and age (<80 or >80), and allocated in random blocks of four, six, and eight. Age over 80 has been shown to be a major risk of complications following ankle fracture. Stratified randomisation has been recommended for clinical trials with less than 200 participants per treatment arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be reported on following CONsolidated Standards Of Reporting Trials (CONSORT) guidelines.
Baseline characteristics will be assessed to ensure no significant differences between treatment groups. Normality of continuous data will be assessed by a Komogorov-Smirnov test. Continuous nonparametric data will be assessed via the Mann-Whitney U test. Continuous parametric data will be assessed with the Students’ t-test. Nominal and categorical data will be assessed with Fisher’s Exact and chi-squared tests respectively. A p-value of <0.05 will be used as threshold of statistical significance.
The primary analysis will include logistic regression to establish the relationship between treatment group and complication rate.
Missing data will be minimised using strategies previously described. If greater than 10% of data is missing, imputation will be employed on advice of the trial statistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/12/2017
Actual
30/03/2018
Date of last participant enrolment
Anticipated
19/12/2020
Actual
Date of last data collection
Anticipated
19/12/2022
Actual
Sample size
Target
110
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9155 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 9156 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 9157 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 17668 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 17669 0
4029 - Herston
Recruitment postcode(s) [3] 17670 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 297681 0
Commercial sector/Industry
Name [1] 297681 0
Stryker Australia Pty Ltd
Country [1] 297681 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd
Woolloongabba
Queensland
Australia 4102
Country
Australia
Secondary sponsor category [1] 296699 0
None
Name [1] 296699 0
Address [1] 296699 0
Country [1] 296699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298752 0
Metro South Human Research Ethics Comittee
Ethics committee address [1] 298752 0
Ethics committee country [1] 298752 0
Australia
Date submitted for ethics approval [1] 298752 0
15/05/2017
Approval date [1] 298752 0
22/06/2017
Ethics approval number [1] 298752 0
HREC/17/QPAH/351

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

Contacts
Principal investigator
Name 78118 0
Dr Matthew Hope
Address 78118 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4201
Country 78118 0
Australia
Phone 78118 0
+61 7 3176 2111
Fax 78118 0
Email 78118 0
[email protected]
Contact person for public queries
Name 78119 0
Paul Tuckett
Address 78119 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4201
Country 78119 0
Australia
Phone 78119 0
+61 7 3176 2111
Fax 78119 0
Email 78119 0
[email protected]
Contact person for scientific queries
Name 78120 0
Paul Tuckett
Address 78120 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba
QLD 4201
Country 78120 0
Australia
Phone 78120 0
+61 7 3176 2111
Fax 78120 0
Email 78120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTransarticular tibiotalocalcaneal nailing versus open reduction and internal fixation for treatment of the elderly ankle fracture: Protocol for a multicentre, prospective, randomised controlled trial.2019https://dx.doi.org/10.1136/bmjopen-2018-026360
N.B. These documents automatically identified may not have been verified by the study sponsor.