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

Sponsor

AO Clinical Investigation and Publishing Documentation (Other)

Overall Status

Completed

CT.gov ID

NCT01134354

Collaborator

(none)

199

Enrollment

Locations

44.1

Duration (Months)

28.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Tibia Fracture (Isolated) Ankle Fracture (Isolated)

Study Design

Study Type:

Observational

Actual Enrollment :

199 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
TEFTOM Patient outcome measure

Outcome Measures

Primary Outcome Measures

Teftom Questionnaire [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Queen Mary Hospital	Hong Kong	China
2	Shanghai Sixth People's Hospital	Shanghai	China	200233
3	Universitätsklinikum Köln	Köln	Germany	50931
4	HOSMAT Hospital	Bangalore	India	560025
5	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Spain	17007
6	Kantonsspital Luzern	Luzern	Switzerland	6000
7	Stadtspital Triemli	Zürich	Switzerland	8063