Ankle FractureNCT01126398
Trauma Expectation Factor Trauma Outcome Measure
An observational study of Ankle Fracture and Pilon Fracture, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture, Pilon Fracture
- What is being tested?
- ankle or distal tibia surgery
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Feb 2007to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who expericenced an ankle or pilon fracture presenting to the emergency room or orthopedic department were asked to participate.
Who may be able to join
- Isolated ankle or distal tibia fracture
- Scheduled for and undergoing surgery for their fracture
- 18 years of age or older
Who cannot join
- 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)
Show all 9Show fewer
- Subject has fracture(s) other than ankle fracture
- Subject is a prisoner
- Fracture occurred more than 4 weeks ago
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Orthopedic Trauma Service, University of Florida - Shands Jacksonville
Jacksonville, Florida, 32207
Department of Orthopaedic Surgery, Hospital for Special Surgery, New York
New York, New York, 10021
Department of Orthopaedic Surgery, New York Presbyterian Hospital, New York
New York, New York, 10021
Brazil1 site
Department of Orthopedic Surgery, Ribeirao Preto Medical School - University of Sao Paulo
Ribeirão Preto, São Paulo, 3900
Canada1 site
Department of Orthopaedic Trauma, Foothills Medical Center, Calgary
Calgary, Alberta, T2N2T9
About this study
Official title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)
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.
Read the detailed description
Aims:
- To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
- To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).
Hypotheses:
H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).
H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.
H#3. Patient and surgeon expectations of final outcome status are different; however, the differences get smaller over time.
- Conditions
- Ankle Fracture, Pilon Fracture
- Being tested
- ankle or distal tibia surgery
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ankle or distal tibia surgeryProcedure or surgery
internal fixation for ankle or distal tibia fracture
| Study group | Role | What they receive |
|---|---|---|
| Ankle / dist. tibia fracture fixation | Not described Receives: Procedure: ankle or distal tibia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-op
Secondary outcomes (1)
Clinician based outcomes
Bony union was assessed using X-Rays.
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Suk, Professor, Principal investigator, Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126398
- Sponsor's protocol ID
- TEFTOM
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)
- ClinicalTrials.gov ID
- NCT01126398
- Acronym / sponsor ID
- TEFTOM
- Conditions
- Ankle Fracture, Pilon Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aims:
- To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
- To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).
Hypotheses:
H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).
H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.
H#3. Patient and surgeon expectations of final outcome status are different; however, the differences get smaller over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle / dist. tibia fracture fixation | – | Procedure: ankle or distal tibia surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who expericenced an ankle or pilon fracture presenting to the emergency room or orthopedic department were asked to participate.
Key inclusion criteria (3 listed)
- Isolated ankle or distal tibia fracture
- Scheduled for and undergoing surgery for their fracture
- 18 years of age or older
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ankle or distal tibia surgeryinternal fixation for ankle or distal tibia fracture | Procedure or surgery | Ankle / dist. tibia fracture fixation |
Primary outcome
patient reported outcomes
Time frame: 12 months post-op
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.
1 secondary outcome
Clinician based outcomes
Time frame: 12 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Suk, Professor principal investigator
Orthopaedic Trauma Service, Universitiy of Florida - Shands Jacksonville
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fracture and Pilon Fracture, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient reported outcomes (time frame: 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.