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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
17/09/2020
Date data sharing statement initially provided
10/03/2020
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
None'
Universal Trial Number (UTN)
U1111-1248-5051
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
Osteoarthritis
Surgery 314596 314596 0 0
Surgical techniques
Musculoskeletal 314597 314597 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
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
Uncontrolled

Outcomes
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

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29390 0
2217 - Kogarah
Recruitment postcode(s) [2] 29391 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 31294 0
2065 - St Leonards
Recruitment postcode(s) [4] 31295 0
2067 - Chatswood
Recruitment postcode(s) [5] 31296 0
2086 - Frenchs Forest
Recruitment postcode(s) [6] 31297 0
2076 - Wahroonga
Recruitment postcode(s) [7] 31298 0
2021 - Moore Park
Recruitment postcode(s) [8] 31299 0
2830 - Dubbo

Funding & Sponsors
Funding source category [1] 305015 0
Self funded/Unfunded
Name [1] 305015 0
Dr Andrew Wines
Address [1] 305015 0
Mater Clinic,Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Country [1] 305015 0
Australia
Funding source category [2] 305175 0
Self funded/Unfunded
Name [2] 305175 0
Dr Michael Symes
Address [2] 305175 0
St George Private Consulting Suites, Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
Country [2] 305175 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI) under the direction of Dr Andrew Wines and Dr Michael Symes
Address
Clinic locations for primary investigators are:
Suite 2, 25 Rocklands Road Wollstonecraft NSW 2065
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 305372 0
Individual
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
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 305412 0
13/03/2020
Approval date [1] 305412 0
12/05/2020
Ethics approval number [1] 305412 0
2020/ETH00615

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 100294 0
+61294090563
Fax 100294 0
Email 100294 0
apw1307@bigpond.com
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
Australia
Phone 100295 0
+61295874720
Fax 100295 0
Email 100295 0
drmichaelsymes@gmail.com
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
Australia
Phone 100296 0
+61299563800
Fax 100296 0
Email 100296 0
cscholes@ebma.com.au

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?
No other documents available
Summary results
No Results