- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126398
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aims:
- 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).
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sao Paulo
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Ribeirao Preto, Sao Paulo, Brazil, 3900
- Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
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Alberta
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Calgary, Alberta, Canada, T2N2T9
- Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
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Florida
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Jacksonville, Florida, United States, 32207
- Orthopedic Trauma Service, University of Florida - Shands Jacksonville
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New York
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New York, New York, United States, 10021
- Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
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New York, New York, United States, 10021
- Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ankle / dist. tibia fracture fixation
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internal fixation for ankle or distal tibia fracture
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient reported outcomes
Time Frame: 12 months post-op
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The 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.
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12 months post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician based outcomes
Time Frame: 12 months post-op
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Bony union was assessed using X-Rays.
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12 months post-op
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael Suk, Professor, Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEFTOM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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