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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01134354
First received: May 28, 2010
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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?

Condition
Tibia Fracture (Isolated)
Ankle Fracture (Isolated)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Teftom Questionnaire [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: June 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TEFTOM
Patient outcome measure

  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

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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134354

Locations
China
Queen Mary Hospital
Hong Kong, China
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Germany
Universitätsklinikum Köln
Köln, Germany, 50931
India
HOSMAT Hospital
Bangalore, India, 560025
Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain, 17007
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Reto Babst, MD Luzerner Kantonsspital
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01134354     History of Changes
Other Study ID Numbers: TEFTOM EURASIA
Study First Received: May 28, 2010
Last Updated: June 18, 2014
Health Authority: Switzerland: Ethikkommission
Austria: Ethikkommission
Hong Kong: Ethics Committee
China: Ethics Committee

Keywords provided by AO Clinical Investigation and Documentation:
Validation study
Outcome Measures
Patient Outcomes Assessment
Patient expectations
Physician patient relationship

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Ankle Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 14, 2014