SOFARI Clinical Outcomes Registry

Not Applicable

Recruiting

• Conditions: Foot and ankle instability; Foot and ankle arthritis; Ankle arthrofibrosis; Disorders of synovium or tendons of the ankle and foot; Hallux deformities; Claw and hammertoe deformities; Morton metatarsalgia; Ingrowing nails; Osteochondritis dissecans of ankle and joints of foot; Other pathologies of the ankle and foot

• Registration Number: ACTRN12620000331932
• Lead Sponsor: Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50000

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported general health status and quality of life as assessed by aggregated EQ5D-5L score.[ Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment];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.[ Baseline (pre-treatment), 3 months, 6 months, 12 months and 2 years following treatment]

Secondary Outcome Measures

Name	Time	Method
The incidence of patients deemed a failure to cure following definitive treatment<br><br>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). [ up to 90 days following treatment]