Clinical trial NCT01134354: The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA
Official title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Fracture (Isolated)
Ankle Fracture (Isolated)
Keywords: Validation study
Outcome Measures
Patient Outcomes Assessment
Patient expectations
Physician patient relationship
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient 18 years of age or older with an 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) or EF followed by ORIF)

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Teftom Questionnaire
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Bangalore
country: India
facility: HOSMAT Hospital
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Luzerner Kantonsspital
name: Reto Babst, MD
role: PRINCIPAL_INVESTIGATOR
References: