Trauma Expectation Factor Trauma Outcome Measure

This study has been completed.
Sponsor:
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01126398
First received: May 17, 2010
Last updated: May 18, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Ankle Fracture
Pilon Fracture
Procedure: ankle or distal tibia surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • patient reported outcomes [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    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:
  • Clinician based outcomes [ Time Frame: 12 months post-op ] [ Designated as safety issue: No ]
    Bony union was assessed using X-Rays.


Enrollment: 204
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ankle / dist. tibia fracture fixation Procedure: ankle or distal tibia surgery
internal fixation for ankle or distal tibia fracture

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126398

Locations
United States, Florida
Orthopedic Trauma Service, University of Florida - Shands Jacksonville
Jacksonville, Florida, United States, 32207
United States, New York
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
New York, New York, United States, 10021
Brazil
Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil, 3900
Canada, Alberta
Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Michael Suk, Professor Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
  More Information

No publications provided

Responsible Party: Professor Michael Suk, University of Florida - Shands Jacksonville
ClinicalTrials.gov Identifier: NCT01126398     History of Changes
Other Study ID Numbers: TEFTOM
Study First Received: May 17, 2010
Last Updated: May 18, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014