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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
SOFARI Clinical Outcomes Registry
Scientific title
Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI) Registry : A quality clinical outcomes registry of patients treated in private practice
Secondary ID [1] 300595 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot and ankle instability 316326 0
Foot and ankle arthritis
316327 0
Ankle arthrofibrosis 316328 0
Disorders of synovium or tendons of the ankle and foot 316329 0
Hallux deformities 316330 0
Claw and hammertoe deformities 316331 0
Morton metatarsalgia 316332 0
Ingrowing nails 316333 0
Osteochondritis dissecans of ankle and joints of foot 316334 0
Other pathologies of the ankle and foot 316335 0
Condition category
Condition code
Musculoskeletal 314595 314595 0 0
Surgery 314596 314596 0 0
Surgical techniques
Musculoskeletal 314597 314597 0 0
Other muscular and skeletal disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 316900 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group

Primary outcome [1] 322926 0
Patient-reported general health status and quality of life as assessed by aggregated EQ5D-5L score.
Timepoint [1] 322926 0
Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment
Primary outcome [2] 322927 0
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.
Timepoint [2] 322927 0
Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment
Secondary outcome [1] 380259 0
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).
Timepoint [1] 380259 0
up to 90 days following treatment

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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
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

Study design
Natural history
Defined population
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.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 31298 0
2021 - Moore Park
Recruitment postcode(s) [2] 31294 0
2065 - St Leonards
Recruitment postcode(s) [3] 29391 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 31295 0
2067 - Chatswood
Recruitment postcode(s) [5] 31297 0
2076 - Wahroonga
Recruitment postcode(s) [6] 31296 0
2086 - Frenchs Forest
Recruitment postcode(s) [7] 35555 0
2145 - Westmead
Recruitment postcode(s) [8] 35553 0
2170 - Liverpool
Recruitment postcode(s) [9] 29390 0
2217 - Kogarah
Recruitment postcode(s) [10] 35554 0
2560 - Campbelltown
Recruitment postcode(s) [11] 36102 0
2756 - Windsor
Recruitment postcode(s) [12] 31299 0
2830 - Dubbo

Funding & Sponsors
Funding source category [1] 305015 0
Self funded/Unfunded
Name [1] 305015 0
Dr Andrew Wines
Country [1] 305015 0
Funding source category [2] 305175 0
Self funded/Unfunded
Name [2] 305175 0
Dr Michael Symes
Country [2] 305175 0
Primary sponsor type
Other Collaborative groups
Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI) under the direction of Dr Andrew Wines and Dr Michael Symes
Clinic locations for primary investigators are:
Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
Secondary sponsor category [1] 305372 0
Name [1] 305372 0
Corey Scholes
Address [1] 305372 0
EBM Analytics
119 Willoughby Road, Crows Nest, 2065, New South Wales
Country [1] 305372 0

Ethics approval
Ethics application status
Ethics committee name [1] 305412 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [1] 305412 0
St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street, Darlinghurst NSW 2010
Ethics committee country [1] 305412 0
Date submitted for ethics approval [1] 305412 0
Approval date [1] 305412 0
Ethics approval number [1] 305412 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 100294 0
Dr Andrew Wines
Address 100294 0
Clinic location for Dr Wines: Suite 2, Mater Clinic 25 Rocklands Road Wollstonecraft NSW 2065
Country 100294 0
Phone 100294 0
Fax 100294 0
Email 100294 0
Contact person for public queries
Name 100295 0
Dr Michael Symes
Address 100295 0
Clinic location for Dr Symes: Suite 5, Level 2, 19 Kensington Street, Kogarah, NSW, 2217
Country 100295 0
Phone 100295 0
Fax 100295 0
Email 100295 0
Contact person for scientific queries
Name 100296 0
Dr Corey Scholes
Address 100296 0
EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
Country 100296 0
Phone 100296 0
Fax 100296 0
Email 100296 0

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

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.