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Trial registered on ANZCTR


Registration number
ACTRN12618001971224
Ethics application status
Approved
Date submitted
5/11/2018
Date registered
6/12/2018
Date last updated
19/11/2019
Date data sharing statement initially provided
6/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Should Ankle Syndesmosis Screws be Removed? - Medium Term Outcomes with a Minimum of Five Years Follow-up
Scientific title
Should Ankle Syndesmosis Screws be Removed? - Medium Term Follow-up Comparing Screw Retention with Screw Removal Following Ankle Fracture Fixation
Secondary ID [1] 296426 0
Nil known
Universal Trial Number (UTN)
U1111-1218-5150
Trial acronym
ASSET - Ankle Syndesmosis Screw Extended Term Follow-up Study
Linked study record
ACTRN12611000397910 is the parent study. It was the original randomised control trial. Our current application is a follow-up to the patients in the original RCT.

Health condition
Health condition(s) or problem(s) studied:
Ankle fractures requiring syndesmosis screw fixation 310181 0
Condition category
Condition code
Injuries and Accidents 308930 308930 0 0
Fractures
Surgery 308931 308931 0 0
Surgical techniques
Musculoskeletal 309065 309065 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Our intervention group is of those patents who did not have a removal of ankle syndesmosis screws. We are reviewing their outcomes five years post surgery with their screw still in situ in a clinical setting where we will assess patients outcomes using various scoring systems and repeat xrays of their ankles as well as retrospective review their electronic hospital clinical notes and imaging over the past 5 years to determine any complications prior to our 5-year follow-up.
Intervention code [1] 312753 0
Diagnosis / Prognosis
Comparator / control treatment
Removal of ankle syndesmosis screws at three months following fixation surgery. This is currently standard practice. We will review these patients in the same manner as the exposure group ie clinical review, outcome scores, repeat imaging and retrospective review of their electronic hospital records.
Control group
Active

Outcomes
Primary outcome [1] 307941 0
Olerud-Molander ankle score (OMAS)
Timepoint [1] 307941 0
Assessment performed five years postoperatively
Secondary outcome [1] 353398 0
American Academy of Orthopaedic Surgeons foot and ankle core score (AAOSFACS)
Timepoint [1] 353398 0
Assessment performed five years postoperatively
Secondary outcome [2] 353399 0
Pain on visual analogue scale (VAS)
Timepoint [2] 353399 0
Assessment performed five years postoperatively
Secondary outcome [3] 353400 0
Range of motion with goniometer
Timepoint [3] 353400 0
Assessment performed five years postoperatively
Secondary outcome [4] 353401 0
American Orthopaedic Foot and Ankle Society (AOFAS) score of hindfoot
Timepoint [4] 353401 0
Assessment performed five years postoperatively
Secondary outcome [5] 353402 0
Muscular trophicity measure of the leg (Calf girth)
Timepoint [5] 353402 0
Assessment performed five years postoperatively
Secondary outcome [6] 353403 0
Radiological loss of reduction
Timepoint [6] 353403 0
Assessment performed five years postoperatively
Secondary outcome [7] 353404 0
Implant failure. This will be checked with x-ray imaging at the time of clinical consultation
Timepoint [7] 353404 0
Assessment performed five years postoperatively
Secondary outcome [8] 353405 0
Rate of secondary surgery. This will be checked by assessing patient records and from patient-reporting.
Timepoint [8] 353405 0
Assessment performed five years postoperatively

Eligibility
Key inclusion criteria
Patients will be identified from the previous study database from the original randomised control trial (Boyle, M, Gao, R, Frampton, C et al. Removal of the syndesmotic screw after the surgical treatment of a fracture of the ankle in adult patients does not affect one-year outcomes (2014) Bone and Joint Journal. 96 (12).) and invited by telephone to return for follow-up. Our original inclusion criteria were patients who were between the ages of 16 and 65 with a displaced fibular fracture with associated tibiofibular diastasis.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Our original exclusion criteria was open fractures, preceding ankle abnormality, neurovascular injury, plafond injury or posterior maleollar fracture involving >10% of joint surface, polytrauma, diaphysial tibia fracture, pathological fracture, cognitive impairment or pregnancy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The difference in Olerud-Molander ankle score between the two groups that has been assumed to be of clinical interest is 10 points. Power calculations indicate that in order to detect a 10 point difference in the Olerud-Molander ankle score between groups (assuming mean 87, SD 12), with an 90% power, we will require 31 patients in each group (a total of 62 patients). Nevertheless, we will endeavour to recall as many patients are possible for follow-up outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2020
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment outside Australia
Country [1] 20983 0
New Zealand
State/province [1] 20983 0

Funding & Sponsors
Funding source category [1] 301026 0
Hospital
Name [1] 301026 0
Middlemore Hospital and North Shore Hospital
Country [1] 301026 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 300614 0
Hospital
Name [1] 300614 0
Manukau Surgical Centre
Address [1] 300614 0
Private Bag 93311
Otahuhu
Auckland 1640
Country [1] 300614 0
New Zealand
Secondary sponsor category [2] 300662 0
Hospital
Name [2] 300662 0
North Shore Hospital
Address [2] 300662 0
Private Bag 93-503
Takapuna
Auckland 0740
Country [2] 300662 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301781 0
New Zealand Health and Disability Ethics Commitees
Ethics committee address [1] 301781 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 301781 0
New Zealand
Date submitted for ethics approval [1] 301781 0
Approval date [1] 301781 0
17/10/2018
Ethics approval number [1] 301781 0
18/NTA/161

Summary
Brief summary
Certain ankle fractures require surgical fixation, with a subset of these ankle fractures also requiring screw fixation of syndesmotic ligamentous injuries. Screw stabilisation of the disrupted ankle syndesmosis maintains reduction as healing of the distal tibiofibular ligaments occurs. It has previously been thought that syndesmosis screws may contribute to ankle dysfunction by restricting the normal motion between the tibia and fibula. Screw removal, breakage, or loosening may restore motion but can permit loss of reduction if these occur before complete ligamentous healing. In 2014, we published an article in the Bone and Joint Journal, demonstrating that there is no difference in removing or retaining ankle syndesmosis screws at one-year follow-up. At the time of publication, our study, entitled “Removal of the syndesmotic screw after the surgical treatment of a fracture of the ankle in adult patients does not affect one-year outcomes”, was voted by the American Academy of Orthopaedic Surgeons (AAOS) as one of the top 15 studies (from a cohort of 856 studies) most likely to impact Orthopaedic Surgeons’ practice in the world.
One of the limitations in our initial study was the short duration of follow-up of one year. The aim of this current study is to review the patients who participated in the initial study and assess the medium-term outcomes in these patients. At the time of follow-up, we will have a minimum of five years follow-up results from this patient cohort.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88086 0
Dr Ryan Gao
Address 88086 0
Department of Orthopaedics
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 88086 0
New Zealand
Phone 88086 0
+64 021 024 22213
Fax 88086 0
Email 88086 0
[email protected]
Contact person for public queries
Name 88087 0
Ryan Gao
Address 88087 0
Department of Orthopaedics
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 88087 0
New Zealand
Phone 88087 0
+64 021 024 22213
Fax 88087 0
Email 88087 0
[email protected]
Contact person for scientific queries
Name 88088 0
Ryan Gao
Address 88088 0
Department of Orthopaedics
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 88088 0
New Zealand
Phone 88088 0
+64 021 024 22213
Fax 88088 0
Email 88088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data from our research will be published and presented with all personal identifiable data removed
When will data be available (start and end dates)?
Our data will be available when our findings are published. Data will be stored/made available for maximum of 10 years, at which point it will be destroyed according to our standard hospital protocols
Available to whom?
Data will be available to anyone who would like to review our data or publications.
Available for what types of analyses?
Data will be available for any appropriate analysis
How or where can data be obtained?
Access to data will be made through contacting the principle investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
55Study protocol    376257-(Uploaded-30-10-2018-16-40-37)-Study-related document.pdf
56Ethical approval    376257-(Uploaded-30-10-2018-16-40-59)-Study-related document.pdf
57Informed consent form    376257-(Uploaded-30-10-2018-16-43-56)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
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