The Role of Patient Expectations in Traumatic Orthopedic Outcomes-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?

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Key information

Conditions

Tibia Fracture (Isolated) Ankle Fracture (Isolated) Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital, Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Teftom Questionnaire

Time frame: one year

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Jun 2, 2010
Registry last updated: Jun 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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