The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA
The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
Design:
Prediction trial, up to 10 sites in Asia and Europe
Goal:
To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM).
Primary aim:
To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population.
Secondary aim:
To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.
Key questions related to patient and surgeon expectations:
- How different, or similar, are patient and surgeon expectations?
- Do expectations change over time?
- Do patient expectations predict outcomes in validated measures use today?
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Bangalore, India, 560025
- HOSMAT Hospital
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Hong Kong, Kina
- Queen Mary Hospital
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Shanghai, Kina, 200233
- Shanghai Sixth People's Hospital
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Girona, Spania, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
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Luzern, Sveits, 6000
- Kantonsspital Luzern
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Zürich, Sveits, 8063
- Stadtspital Triemli
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Köln, Tyskland, 50931
- Universitätsklinikum Köln
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Isolated ankle or distal tibia fracture
Scheduled for and undergoing one of the following surgeries for their fracture:
- Open fracture and internal fixation (ORIF)
- external fixation (EF)
- EF followed by ORIF
- 18 years of age or older
- Understand and read country national language at elementary level
- Able to understand the purpose of the clinical trial,
- Able and willing to conduct all follow-up visits
- Signed informed consent
Exclusion Criteria:
- Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture.
- Subject has disease entity, or condition that precludes likelihood of bony union (e.g., metastatic cancer, metabolic bone disease).
- Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires.
- Subject is participating in other competing clinical research that may interfere with participation in this research.
- Subject is unlikely to attend study related follow-up visits.
- Subject has poly-trauma (more than one organ system compromised)
- Subject has additional fracture(s) other than ankle fracture
- Subject is a prisoner
- Fracture occurred more than 28 days before surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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TEFTOM
Patient outcome measure
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Teftom Questionnaire
Tidsramme: one year
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one year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Reto Babst, MD, Luzerner Kantonsspital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TEFTOM EURASIA
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