Trauma Expectation Factor Trauma Outcome Measure

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Pilon Fracture; Ankle Fracture

Treatments: Procedure: ankle or distal tibia surgery

Study type: Observational

Funder types: Other

Identifiers

NCT01126398

TEFTOM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

204 participants in 1 patient group

Ankle / dist. tibia fracture fixation

Treatment:

Procedure: ankle or distal tibia surgery