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Trauma Expectation Factor Trauma Outcome Measure

The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01126398
Enrollment
204
Registered
2010-05-19
Start date
2007-02-28
Completion date
2010-02-28
Last updated
2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture, Pilon Fracture

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.

Interventions

PROCEDUREankle or distal tibia surgery

internal fixation for ankle or distal tibia fracture

Sponsors

AO Clinical Investigation and Publishing Documentation
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient reported outcomes12 months post-opThe patient reported outcome includes the Trauma Outcome Measure (TOM), the AAOS Foot and Ankle Core Score, the Foot and Ankle Outcome Scores (FAOS), a 10mm visual analogue scale (VAS), and the SF-36.

Secondary

MeasureTime frameDescription
Clinician based outcomes12 months post-opBony union was assessed using X-Rays.

Countries

Brazil, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026