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Completed

NCT Number: NCT01126398

Trauma Expectation Factor Trauma Outcome Measure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo, Ribeirão Preto, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ankle or distal tibia surgery

Procedure

internal fixation for ankle or distal tibia fracture

Primary outcomes

  1. patient reported outcomes

    Time frame: 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 outcomes

  1. Clinician based outcomes

    Time frame: 12 months post-op

    Bony union was assessed using X-Rays.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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