Trauma Expectation Factor Trauma Outcome Measure

Ankle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126398
• Other study ID #: TEFTOM
• Status: Completed
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone
• Pilon Fracture

Intervention

Procedure:
• ankle or distal tibia surgery
internal fixation for ankle or distal tibia fracture

Locations

Country	Name	City	State
Brazil	Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo	Ribeirao Preto	Sao Paulo
Canada	Department of Orthopaedic Trauma, Foothills Medical Center, Calgary	Calgary	Alberta
United States	Orthopedic Trauma Service, University of Florida - Shands Jacksonville	Jacksonville	Florida
United States	Department of Orthopaedic Surgery, Hospital for Special Surgery, New York	New York	New York
United States	Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinician based outcomes	Bony union was assessed using X-Rays.	12 months post-op