Supination-external Rotation Ankle FracturesNCT02599441
Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures
An observational study of Supination-external Rotation Ankle Fractures, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supination-external Rotation Ankle Fractures
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 2 Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients who have been diagnosed with unstable supination-external rotation type ankle fractures
Who may be able to join
- willing \& able to provide written informed consent
- at least 18 years-old
- have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray
Who cannot join
- pregnant (females)
- prisoners
- open fracture
- clinical signs of foot deformity
- previous foot trauma or surgery on the affected foot
- significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
- unable to stand in the weight bearing position during the CT scan
Trial locations and contacts
1 site in 1 country.
United States1 site
UBMD Orthopaedics & Sports Medicine
Buffalo, New York, 14226
About this study
Official title: Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation 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 |
|---|---|---|
| Ankle fracture cases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial Clear Space Distance in the Ankle Joint
measured on weight bearing CBCT
Measured: Baseline- single-day study
Secondary outcomes (2)
Medial Clear Space on Gravity Stress Xray
Measured: Baseline
Medial Clear Space on Standard Xray
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Supination-external Rotation Ankle FracturesStudies 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
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Marzo, State University of New York at Buffalo
- Investigators
- John Marzo, MD, Principal investigator, UBMB Orthopaedics & Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599441
- Sponsor's protocol ID
- 733368-1
- Status last verified
- Oct 2019
- First submitted
- 4 Nov 2015
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
- ClinicalTrials.gov ID
- NCT02599441
- Acronym / sponsor ID
- 733368-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle fracture cases | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with unstable supination-external rotation type ankle fractures
Key inclusion criteria (3 listed)
- willing \& able to provide written informed consent
- at least 18 years-old
- have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray
Key exclusion criteria (7 listed)
- pregnant (females)
- prisoners
- open fracture
- clinical signs of foot deformity
- previous foot trauma or surgery on the affected foot
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
Medial Clear Space Distance in the Ankle Joint
Time frame: Baseline- single-day study
measured on weight bearing CBCT
2 secondary outcomes
Medial Clear Space on Gravity Stress Xray
Time frame: Baseline
Medial Clear Space on Standard Xray
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
John Marzo, MD principal investigator
UBMB Orthopaedics & Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supination-external Rotation Ankle Fractures, run by State University of New York at Buffalo at 1 site in United States.
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 7 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medial Clear Space Distance in the Ankle Joint (time frame: Baseline- single-day study). 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 25 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.