Ankle FractureNCT01444144
Ankle Fracture Treatment in the Elderly
An observational study of Ankle Fracture, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Fracture union
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 3 Apr 2011
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.
Who may be able to join
- at least 55 years of age at time of surgery
- receiving treatment for ankle fractures
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: Ankle Fracture Treatment in the Elderly, at Risk Population
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.
Read the detailed description
This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older
- Conditions
- Ankle Fracture
- Being tested
- Fracture union
- Keywords
- Ankle, Fracture, Elderly, At-risk Population, Ankle Fracture in at-risk elderly population
- Medical subject headings
- Ankle Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture unionOther
Retrospective records review post-operatively until fracture resolved.
| Study group | Role | What they receive |
|---|---|---|
| Ankle Fracture | Patients aged 55 years at time of surgery undergoing treatment for ankle fractures. Receives: Other: Fracture union |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of Fracture Union
Retrospective records review tracking ankle fractures post-operatively until fracture heals.
Measured: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
Secondary outcomes (1)
Post-operative Complications
Retrospective record review tracking complications post-operatively until resolved.
Measured: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startMar 2011
- Primary completion3 Apr 2011
- Study completion3 Apr 2011
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kalia K Sadasivan, M.D., Principal investigator, University of Florida Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444144
- Sponsor's protocol ID
- 146-2011
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2011
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Fracture Treatment in the Elderly, at Risk Population
- ClinicalTrials.gov ID
- NCT01444144
- Acronym / sponsor ID
- 146-2011
- Conditions
- Ankle Fracture
- Keywords
- Ankle, Fracture, Elderly, At-risk Population, Ankle Fracture in at-risk elderly population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- 3 Apr 2011 (actual)
- Study completion
- 3 Apr 2011 (actual)
- First posted
- 30 Sep 2011 (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.
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.
Detailed description
This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle Fracture | – | Other: Fracture unionPatients aged 55 years at time of surgery undergoing treatment for ankle fractures. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At-risk population, at least 55 years of age at time of surgery receiving treatment for ankle fractures.
Key inclusion criteria (2 listed)
- at least 55 years of age at time of surgery
- receiving treatment for ankle fractures
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Fracture unionRetrospective records review post-operatively until fracture resolved. | Other | Ankle Fracture |
Primary outcome
Status of Fracture Union
Time frame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.
Retrospective records review tracking ankle fractures post-operatively until fracture heals.
1 secondary outcome
Post-operative Complications
Time frame: Post-operatively until documentation that complications resolved, assessed up to seven months following surgery.
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 3 Oct 2017.
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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.
Kalia K Sadasivan, M.D. principal investigator
University of Florida Department of Orthopaedics and Rehabilitation
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 Ankle Fracture, run by University of Florida 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 2 inclusion and 1 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 3 Oct 2017. 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?
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?
Status of Fracture Union (time frame: Post-operatively until documentation of fracture healing, assessed up to seven months following surgery.). 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 3 Oct 2017.