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

AO Clinical Investigation and Publishing Documentation

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01134354

TEFTOM EURASIA

Details and patient eligibility

About

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?

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

199 participants in 1 patient group

TEFTOM

Description:

Patient outcome measure