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Trial registered on ANZCTR
Registration number
ACTRN12620000331932
Ethics application status
Approved
Date submitted
20/02/2020
Date registered
10/03/2020
Date last updated
30/06/2024
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
SOFARI Clinical Outcomes Registry
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Scientific title
Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI) Registry : A quality clinical outcomes registry of patients treated in private practice
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Secondary ID [1]
300595
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None'
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Universal Trial Number (UTN)
U1111-1248-5051
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Foot and ankle instability
316326
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Foot and ankle arthritis
316327
0
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Ankle arthrofibrosis
316328
0
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Disorders of synovium or tendons of the ankle and foot
316329
0
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Hallux deformities
316330
0
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Claw and hammertoe deformities
316331
0
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Morton metatarsalgia
316332
0
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Ingrowing nails
316333
0
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Osteochondritis dissecans of ankle and joints of foot
316334
0
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Other pathologies of the ankle and foot
316335
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Condition category
Condition code
Musculoskeletal
314595
314595
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0
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Osteoarthritis
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Surgery
314596
314596
0
0
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Surgical techniques
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Musculoskeletal
314597
314597
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
2
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Target follow-up type
Years
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Description of intervention(s) / exposure
This registry will collate clinical information and patient-reported outcomes for private patients presenting with foot or ankle pathologies, and determine the associated specific patient/pathology/management factors at up to 2 years of follow-up.
Participant involvement will be as per standards of care. Patients will undergo consultation for diagnosis and treatment of foot and ankle pathologies, including the collection of demographic data, patient medical history, radiological findings and diagnosis. Clinical outcomes at baseline and post treatment follow up will be assessed via completion of general health, expectation/satisfaction and region specific questionnaires. Clinical information will be collected within the clinic practice management systems during consultation or follow up as per standard treatment pathways, and collated within the SOFARI registry for subsequent review and analysis.
Participants to the SOFARI clinical outcomes registry will be provided information stating the purpose of the clinical outcomes registry, and the inclusion of their clinical data for research and monitoring purposes. Patients will be provided an opportunity to actively consent or decline the use of their medical records and clinical information for the clinical registry.
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Intervention code [1]
316900
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
322926
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Patient-reported general health status and quality of life as assessed by aggregated EQ5D-5L score.
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Assessment method [1]
322926
0
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Timepoint [1]
322926
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Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment
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Primary outcome [2]
322927
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Patient-reported pain, symptoms, activities of daily living, sport and recreation function and foot and ankle related quality of life as assessed by aggregated Foot and Ankle Outcome (FAOS) score.
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Assessment method [2]
322927
0
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Timepoint [2]
322927
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Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment
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Secondary outcome [1]
380259
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The incidence of patients deemed a "failure to cure" following definitive treatment
Composite outcome consisting of insufficient improvement in patient reported outcome measures (EQ5D-5L; FAOS); adverse findings (e.g. revisions, reoperations or complications) determined at post-treatment clinical follow up or radiological imaging (eg.non-union).
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Assessment method [1]
380259
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Timepoint [1]
380259
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up to 90 days following treatment
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Eligibility
Key inclusion criteria
Private patients attending for treatment of foot and ankle pathologies by principal investigators.
Eligible for one of the following prespecified diagnoses:
Ankle arthritis; Ankle arthrofibrosis; Osteochondral lesions of talar dome and tibial plafond;
Lateral ligament instability; Syndesmotic instability; Posterior ankle impingement; Subtalar osteoarthritis; Achilles tendinosis; Tibialis posterior tendon dysfunction; Peroneal tendinopathy; Tarsal tunnel syndrome; Tarsometatarsal joint osteoarthritis;
1st metatarsophalangeal joint arthritis; Hallux valgus deformity (bunions); Claw and hammertoe deformities; 2/3 and 3/4 Morton's neuromas; Ingrown toenails; Or other foot and ankle pathologies.
Received information package associated with opt-out consent process.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder)
Revocation of consent for research use of personal data
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
Sample size calculations were based upon a rule of thumb of 10 treatment failure events per variable entered into a binary logistic regression model, assuming clinical failure rates for specific procedures taken from similar cohorts reported in the literature. Final target sample sizes for each cohort were calculated to have 80% power to detect a significant effect for 5 predictor variables, allowing for up to 10% protocol non-compliance and a 2-sided alpha of 0.05.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2020
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Actual
1/06/2020
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Date of last participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last data collection
Anticipated
1/06/2027
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Actual
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Sample size
Target
50000
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Accrual to date
14404
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
31298
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2021 - Moore Park
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Recruitment postcode(s) [2]
31294
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2065 - St Leonards
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Recruitment postcode(s) [3]
29391
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2065 - Wollstonecraft
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Recruitment postcode(s) [4]
31295
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2067 - Chatswood
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Recruitment postcode(s) [5]
31297
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2076 - Wahroonga
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Recruitment postcode(s) [6]
31296
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2086 - Frenchs Forest
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Recruitment postcode(s) [7]
35555
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2145 - Westmead
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Recruitment postcode(s) [8]
35553
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2170 - Liverpool
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Recruitment postcode(s) [9]
29390
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2217 - Kogarah
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Recruitment postcode(s) [10]
35554
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2560 - Campbelltown
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Recruitment postcode(s) [11]
36102
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2756 - Windsor
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Recruitment postcode(s) [12]
31299
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2830 - Dubbo
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Funding & Sponsors
Funding source category [1]
305015
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Self funded/Unfunded
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Name [1]
305015
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Dr Andrew Wines
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Address [1]
305015
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Mater Clinic,Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
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Country [1]
305015
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Australia
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Funding source category [2]
305175
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Self funded/Unfunded
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Name [2]
305175
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Dr Michael Symes
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Address [2]
305175
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St George Private Consulting Suites, Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
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Country [2]
305175
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Australia
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Funding source category [3]
316845
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Self funded/Unfunded
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Name [3]
316845
0
Dr Rajat Mittal
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Address [3]
316845
0
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Country [3]
316845
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Australia
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Funding source category [4]
316846
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Self funded/Unfunded
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Name [4]
316846
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Dr Mayuran Suthersan
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Address [4]
316846
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Country [4]
316846
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI)
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Address
Clinic locations for primary investigators are:
Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
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Country
Australia
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Secondary sponsor category [1]
305372
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Individual
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Name [1]
305372
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Corey Scholes
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Address [1]
305372
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EBM Analytics
119 Willoughby Road, Crows Nest, 2065, New South Wales
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Country [1]
305372
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305412
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St Vincent's Hospital Sydney Human Research Ethics Committee
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Ethics committee address [1]
305412
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St Vincent’s Hospital Translational Research Centre 97-105 Boundary Street, Darlinghurst NSW 2010
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Ethics committee country [1]
305412
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Australia
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Date submitted for ethics approval [1]
305412
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13/03/2020
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Approval date [1]
305412
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12/05/2020
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Ethics approval number [1]
305412
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2020/ETH00615
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Summary
Brief summary
The aim of this protocol is to design and implement a clinical quality orthopaedic registry for patients presenting to Drs Michael Symes and Andrew Wines (orthopaedic surgeons) with foot and ankle pathologies. The purpose of the registry is to report patient outcomes after treatment through a retrospective and prospective, consecutive observational cohort study design. This clinical registry will collate and store patient demographic, treatment and clinical data as well as patient outcomes collected routinely as part of the standard clinical pathway for foot and ankle pathology treatments. Outcomes will include clinical outcomes, patient reported outcomes and rates of adverse events following treatment. Recruitment will include all patients presenting with foot and ankle pathology to the principal investigators (Drs Michael Symes and Andrew Wines) at their clinical practices. Patients will be presented with a Participant Information Sheet to inform them of the nature of the registry and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-out approach. Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators. Patients will in addition be requested to complete a set of questionnaires (EQ-5D-5L, Foot and Ankle Outcome Score, FAOS) to enable evaluation of patient reported outcomes as part of their baseline and post- treatment follow up. The clinical outcomes of individual patients will be monitored for up to 5 years.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
100294
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Dr Andrew Wines
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Address
100294
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Clinic location for Dr Wines: Suite 2, Mater Clinic 25 Rocklands Road Wollstonecraft NSW 2065
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Country
100294
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Australia
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Phone
100294
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+61294090563
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Fax
100294
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Email
100294
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apw1307@bigpond.com
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Contact person for public queries
Name
100295
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Michael Symes
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Address
100295
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Clinic location for Dr Symes: Suite 5, Level 2, 19 Kensington Street, Kogarah, NSW, 2217
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Country
100295
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Australia
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Phone
100295
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+61295874720
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Fax
100295
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Email
100295
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drmichaelsymes@gmail.com
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Contact person for scientific queries
Name
100296
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Corey Scholes
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Address
100296
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EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
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Country
100296
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Australia
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Phone
100296
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+61299563800
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Fax
100296
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Email
100296
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cscholes@ebma.com.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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