The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA

The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA

Design:

Prediction trial, up to 10 sites in Asia and Europe

Goal:

To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM).

Primary aim:

To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population.

Secondary aim:

To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.

Key questions related to patient and surgeon expectations:

• How different, or similar, are patient and surgeon expectations?
• Do expectations change over time?
• Do patient expectations predict outcomes in validated measures use today?

Study Overview

• Status: Completed
• Conditions: Tibia Fracture (Isolated); Ankle Fracture (Isolated)

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Mary Hospital
  • Shanghai, China, 200233
    • Shanghai Sixth People's Hospital
• Germany
  • Köln, Germany, 50931
    • Universitatsklinikum Koln
• India
  • Bangalore, India, 560025
    • HOSMAT Hospital
• Spain
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Doctor Josep Trueta
• Switzerland
  • Luzern, Switzerland, 6000
    • Kantonsspital Luzern
  • Zürich, Switzerland, 8063
    • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient 18 years of age or older with an isolated ankle or distal tibia fracture, scheduled for and undergoing one of the following surgeries for their fracture (Open fracture and internal fixation (ORIF, external fixation (EF) or EF followed by ORIF)

Description

Inclusion Criteria:

• Isolated ankle or distal tibia fracture

• Scheduled for and undergoing one of the following surgeries for their fracture:

  • Open fracture and internal fixation (ORIF)
  • external fixation (EF)
  • EF followed by ORIF
• 18 years of age or older
• Understand and read country national language at elementary level
• Able to understand the purpose of the clinical trial,
• Able and willing to conduct all follow-up visits
• Signed informed consent

Exclusion Criteria:

• Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture.
• Subject has disease entity, or condition that precludes likelihood of bony union (e.g., 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 poly-trauma (more than one organ system compromised)
• Subject has additional fracture(s) other than ankle fracture
• Subject is a prisoner
• Fracture occurred more than 28 days before surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TEFTOM; Patient outcome measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Teftom Questionnaire	one year

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Reto Babst, MD, Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Outcome Measures; Validation study; Patient expectations; Physician patient relationship; Patient Outcomes Assessment
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures; Ankle Fractures
• Other Study ID Numbers: TEFTOM EURASIA