Clinical trial NCT01126398: Trauma Expectation Factor Trauma Outcome Measure
Official title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Fracture
Pilon Fracture
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who expericenced an ankle or pilon fracture presenting to the emergency room or orthopedic department were asked to participate.

Brief summary: This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.

Detailed description: Aims:

1. To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
2. To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).

Hypotheses:

H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).

H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.

H#3. Patient and surgeon expectations of final outcome status are different; however, the differences get smaller over time.

Eligibility criteria: Inclusion Criteria:

* Isolated ankle or distal tibia fracture
* Scheduled for and undergoing surgery for their fracture
* 18 years of age or older

Exclusion Criteria:

* Subject has previously undergone internal fixation surgery for this ankle fracture
* Subject has disease entity, or condition that precludes likelihood of bony union (eg, 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 polytrauma (more than one organ system compromised)
* Subject has fracture(s) other than ankle fracture
* Subject is a prisoner
* Fracture occurred more than 4 weeks ago

Primary outcomes:
measure: patient reported outcomes
timeFrame: 12 months post-op
Secondary outcomes:
measure: Clinician based outcomes
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Orthopedic Trauma Service, University of Florida - Shands Jacksonville
state: Florida
city: New York
country: United States
facility: Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
state: New York
city: New York
country: United States
facility: Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York
state: New York
city: Ribeirao Preto
country: Brazil
facility: Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
state: Sao Paulo
city: Calgary
country: Canada
facility: Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
state: Alberta
Study officials:
affiliation: Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
name: Michael Suk, Professor
role: PRINCIPAL_INVESTIGATOR
References: