Tibia Fracture (Isolated)NCT01134354
The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA
An observational study of Tibia Fracture (Isolated) and Ankle Fracture (Isolated), run by AO Clinical Investigation and Publishing Documentation at 7 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibia Fracture (Isolated), Ankle Fracture (Isolated)
- How many people
- 199 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Jun 2010to Feb 2014
- 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: Patient 18 years of age or older with an 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) or EF followed by ORIF)
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 9Show fewer
- Subject has additional fracture(s) other than ankle fracture
- Subject is a prisoner
- Fracture occurred more than 28 days before surgery
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
China2 sites
Queen Mary Hospital
Hong Kong
Shanghai Sixth People's Hospital
Shanghai, 200233
Switzerland2 sites
Kantonsspital Luzern
Lucerne, 6000
Stadtspital Triemli
Zurich, 8063
About this study
Official title: The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
Design:
Prediction trial, up to 10 sites in Asia and Europe
Read more
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?
- Keywords
- Validation study, Outcome Measures, Patient Outcomes Assessment, Patient expectations, Physician patient relationship
- Medical subject headings
- Tibial Fractures, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEFTOM | Patient outcome measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teftom Questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibia Fracture (Isolated)Studies 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
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto Babst, MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134354
- Sponsor's protocol ID
- TEFTOM EURASIA
- Status last verified
- Jun 2014
- First submitted
- 28 May 2010
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
- ClinicalTrials.gov ID
- NCT01134354
- Acronym / sponsor ID
- TEFTOM EURASIA
- Keywords
- Validation study, Outcome Measures, Patient Outcomes Assessment, Patient expectations, Physician patient relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Jun 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.
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?
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEFTOM | – | –Patient outcome measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient 18 years of age or older with an 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) or EF followed by ORIF)
Key inclusion criteria (10 listed)
- Isolated ankle or distal tibia fracture
- Scheduled for and undergoing one of the following surgeries for their fracture:
- 18 years of age or older
- Understand and read country national language at elementary level
- Able to understand the purpose of the clinical trial,
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Teftom Questionnaire
Time frame: one year
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 19 Jun 2014.
Related trials for Tibia Fracture (Isolated)
Recruiting
Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures
Fractures, Bone
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.
Reto Babst, MD principal investigator
Luzerner Kantonsspital
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibia Fracture (Isolated) and Ankle Fracture (Isolated), run by AO Clinical Investigation and Publishing Documentation at 7 sites in 5 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 10 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 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Switzerland, Germany, India, Spain. 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?
Teftom Questionnaire (time frame: one year). 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 19 Jun 2014.