Trauma Expectation Factor Trauma Outcome Measure

NCT01126398 | Completed

• 1 other identifier: TEFTOM
• Study Type: observational
• Target: 204
• Locations: 3 countries
• Sites: 5

Brief Summary

This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.

Conditions

Ankle Fracture; Pilon Fracture

Outcome Measures

Primary Outcomes (1)

• patient reported outcomes

  The patient reported outcome includes the Trauma Outcome Measure (TOM), the AAOS Foot and Ankle Core Score, the Foot and Ankle Outcome Scores (FAOS), a 10mm visual analogue scale (VAS), and the SF-36.

  12 months post-op

Secondary Outcomes (1)

• Clinician based outcomes

  12 months post-op

Study Arms (1)

Ankle / dist. tibia fracture fixation

Procedure: ankle or distal tibia surgery

Interventions

ankle or distal tibia surgery PROCEDURE

internal fixation for ankle or distal tibia fracture

Ankle / dist. tibia fracture fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who expericenced an ankle or pilon fracture presenting to the emergency room or orthopedic department were asked to participate.

You may qualify if:

• Isolated ankle or distal tibia fracture
• Scheduled for and undergoing surgery for their fracture
• years of age or older

You may not qualify if:

• Subject has previously undergone internal fixation surgery for this ankle fracture
• Subject has disease entity, or condition that precludes likelihood of bony union (eg, 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 polytrauma (more than one organ system compromised)
• Subject has fracture(s) other than ankle fracture
• Subject is a prisoner
• Fracture occurred more than 4 weeks ago

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (5)

Orthopedic Trauma Service, University of Florida - Shands Jacksonville

Jacksonville, Florida, 32207, United States

Location

Department of Orthopaedic Surgery, Hospital for Special Surgery, New York

New York, New York, 10021, United States

Location

Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York

New York, New York, 10021, United States

Location

Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo

Ribeirão Preto, São Paulo, 3900, Brazil

Location

Department of Orthopaedic Trauma, Foothills Medical Center, Calgary

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Michael Suk, Professor

  Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 22, 2021

Record last verified: 2010-05

Locations

US (3); BR (1); CA (1)