Trauma Expectation Factor Trauma Outcome Measure

Completed

• Conditions: Pilon Fracture; Ankle Fracture
• Interventions: Procedure: ankle or distal tibia surgery

• Registration Number: NCT01126398
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ankle / dist. tibia fracture fixation	ankle or distal tibia surgery	-

Primary Outcome Measures

Name	Time	Method
patient reported outcomes	12 months post-op	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.

Secondary Outcome Measures

Name	Time	Method
Clinician based outcomes	12 months post-op	Bony union was assessed using X-Rays.

Trial Locations

Locations (5)

Orthopedic Trauma Service, University of Florida - Shands Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York; 🇺🇸 New York, New York, United States

Department of Orthopaedic Trauma, Foothills Medical Center, Calgary; 🇨🇦 Calgary, Alberta, Canada

Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil

Department of Orthopaedic Surgery, Hospital for Special Surgery, New York; 🇺🇸 New York, New York, United States