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)

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.

Study Overview

• Status: Completed
• Conditions: Pilon Fracture; Ankle Fracture
• Intervention / Treatment: Procedure: ankle or distal tibia surgery

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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Ribeirao Preto, Sao Paulo, Brazil, 3900
      • Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Orthopedic Trauma Service, University of Florida - Shands Jacksonville
  • New York
    • New York, New York, United States, 10021
      • Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
    • New York, New York, United States, 10021
      • Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ankle / dist. tibia fracture fixation	Procedure: ankle or distal tibia surgery; internal fixation for ankle or distal tibia fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient reported outcomes	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.	12 months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician based outcomes	Bony union was assessed using X-Rays.	12 months post-op

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Michael Suk, Professor, Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (ESTIMATE): May 19, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: TEFTOM