Ankle FractureNCT02334618
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
An observational study of Ankle Fracture, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ankle Fracture
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 13 Jul 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the University of Utah emergency department with ankle fractures.
Who may be able to join
- Patient is 18 years of age or older
- Patient has an ankle fracture
- Patient speaks English
- Patient weighs between 100 and 250 pounds
- Patient lives in close enough proximity to the hospital to return for all appointments (~100 miles)
Who cannot join
- Patient is younger than 18 years of age
- Patient has multiple fractures that would alter weight bearing protocol
- Patient does not speak English
- Patient weighs less than 100 pounds or more than 250 pounds
- Patient does not live in close enough proximity to the hospital to return for all appointments (~>100 miles)
- Patient has a traumatic brain injury that would make it so they cannot consent
- Patient has diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics Center
Salt Lake City, Utah, 84121
About this study
Official title: Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.
- Conditions
- Ankle Fracture
- Medical subject headings
- Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activity Measure (PAM-13) Questionnaire
A subjective evaluation of perceived compliance with physician instructions
Measured: Follow Up Visits up to 1-Year
Secondary outcomes (1)
X-ray (AP and Lateral)
Subjectively evaluate fracture healing
Measured: Follow Up Visits up to 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startAug 2014
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
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 UtahThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rothberg, University of Utah
- Investigators
- David Rothberg, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334618
- Sponsor's protocol ID
- 73982
- Status last verified
- Aug 2017
- First submitted
- 6 Jan 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures
- ClinicalTrials.gov ID
- NCT02334618
- Acronym / sponsor ID
- 73982
- Conditions
- Ankle Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 8 Jan 2015 (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 use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the University of Utah emergency department with ankle fractures.
Key inclusion criteria (5 listed)
- Patient is 18 years of age or older
- Patient has an ankle fracture
- Patient speaks English
- Patient weighs between 100 and 250 pounds
- Patient lives in close enough proximity to the hospital to return for all appointments (~100 miles)
Key exclusion criteria (7 listed)
- Patient is younger than 18 years of age
- Patient has multiple fractures that would alter weight bearing protocol
- Patient does not speak English
- Patient weighs less than 100 pounds or more than 250 pounds
- Patient does not live in close enough proximity to the hospital to return for all appointments (~>100 miles)
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
Patient Activity Measure (PAM-13) Questionnaire
Time frame: Follow Up Visits up to 1-Year
A subjective evaluation of perceived compliance with physician instructions
1 secondary outcome
X-ray (AP and Lateral)
Time frame: Follow Up Visits up to 1-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 26 Oct 2017.
Related trials for Ankle Fracture
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
Hardware Removal After ORIF of Ankle Fractures
Ankle Fractures
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.
David Rothberg, M.D. principal investigator
University of Utah
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 Utah 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 5 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 26 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?
Patient Activity Measure (PAM-13) Questionnaire (time frame: Follow Up Visits up to 1-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 26 Oct 2017.