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Recruiting NCT07620015

Turkish Version of the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM-TR): A Multi-Centre Validation Study

Conditions: Ankle Fractures, Ankle Injuries

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Utku Gürhan

Location: University of Kyrenia, Dr. Suat Gunsel Hospital - Department of Orthopaedics and Traumatology Kyrenia

Summary

Ankle fractures are common injuries that can affect a patient's mobility, mood, sleep, and everyday life for months. The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is an English-language patient-reported outcome measure developed in Australia to capture this broader rehabilitation experience. No validated Turkish version of A-FORM currently exists. This prospective multi-centre observational study aims to translate the A-FORM into Turkish (A-FORM-TR), culturally adapt it for use in Turkish-speaking patients, and evaluate its psychometric properties. The investigators will recruit 150 adults with a unilateral ankle fracture, treated either surgically or conservatively, from three orthopedic centres in Turkiye and the Turkish Republic of Northern Cyprus. Participants complete the A-FORM-TR together with two established comparator questionnaires (AOFAS Ankle-Hindfoot Score and the Turkish Olerud-Molander Ankle Score). A subset of approximately 50 participants is re-administered the A-FORM-TR after 7 to 14 days to assess test-retest reliability, with a Global Rating of Change item identifying clinically stable patients. Analyses include classical test theory, confirmatory factor analysis, and Rasch measurement analysis.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Radiographically confirmed unilateral ankle fracture (Weber A, B, or C) * Either surgical (open reduction and internal fixation) or conservative (cast, walker boot, or functional brace) treatment completed * Currently in the rehabilitation phase, 3 weeks to 12 months post-injury * Native Turkish speaker, able to read and self-complete a questionnaire * Able and willing to provide written informed consent Exclusion Criteria: * Bilateral ankle fracture * Previous ipsilateral ankle fracture or any prior orthopedic surgery on the same ankle * Pathological fracture (tumour, metastasis, or other underlying bone pathology) * Concurrent significant ipsilateral lower-limb injury (for example pilon fracture, ipsilateral tibial or fibular shaft fracture, ipsilateral femoral or tibial plateau fracture) * Polytrauma (significant head, spine, abdominal, or contralateral lower-limb injury affecting function) * Cognitive or psychiatric impairment precluding self-completion of the questionnaire * Insufficient Turkish literacy * Inability to attend a follow-up visit for the test-retest assessment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07620015). StuddyBuddy aggregates publicly available trial information.