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

Completed

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

• Registration Number: NCT01134354
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-28
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Teftom Questionnaire	one year

Trial Locations

Locations (7)

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

HOSMAT Hospital; 🇮🇳 Bangalore, India

Hospital Universitari de Girona Doctor Josep Trueta; 🇪🇸 Girona, Spain

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

Stadtspital Triemli; 🇨🇭 Zürich, Switzerland