Broken AnkleNCT02736370
Early Weight Bearing for Ankle Fractures
An observational study of Broken Ankle, run by Corewell Health West.
Trial summary
The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Broken Ankle
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Feb 2019
- 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: Patients that present with bimalleolar or trimalleolar ankle fractures
Who may be able to join
- Men and women ages of 18 and up
- Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
- Orthopaedic Trauma Association (OTA) classification of 44A and 44B
- English speaking
- Able and willing to consent
Who cannot join
- Open fractures
- OTA classification of 43 and 44C
- Patients with diabetes mellitus
- No other lower extremity injuries that would affect functional outcomes
- Previous use of walking aides
- Patients with paralysis or hemiplegia
Show all 13Show fewer
- Ankle fractures requiring syndesmotic repair
- Ankle fractures requiring fixation of the posterior malleolar
- Associated neurovascular injury
- Problems maintaining follow up (homeless or not willing to return for follow up)
- Pathological fractures
- Prisoners
- Patients not allowed to bear weight before the 6 week post-operative follow up visit
About this study
Official title: Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.
- Conditions
- Broken Ankle
- Medical subject headings
- Ankle Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome Scores
During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes.
Measured: 12 months post operatively
Secondary outcomes (4)
Return to work
During follow up visits the patients return to work status will be assessed.
Measured: up to 12 months
Fracture Healing
During follow up visits fractures healing will be assessed by physician review of x-rays.
Measured: up to 12 months
Pain Scores
Pain Scores and PROMIS Pain Intensity and Interference questionnaires will be assessed during follow up. These forms will be analyzed together to determine the patients overall pain.
Measured: 12 months post operatively
Post operative complications
Post operative complications will be assessed during follow up visits.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Broken AnkleStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blake W Miller, DO, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736370
- Sponsor's protocol ID
- 2016-081
- Status last verified
- Sep 2023
- First submitted
- 29 Mar 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
- ClinicalTrials.gov ID
- NCT02736370
- Acronym / sponsor ID
- 2016-081
- Conditions
- Broken Ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Apr 2016 (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 observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present with bimalleolar or trimalleolar ankle fractures
Key inclusion criteria (5 listed)
- Men and women ages of 18 and up
- Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
- Orthopaedic Trauma Association (OTA) classification of 44A and 44B
- English speaking
- Able and willing to consent
Key exclusion criteria (13 listed)
- Open fractures
- OTA classification of 43 and 44C
- Patients with diabetes mellitus
- No other lower extremity injuries that would affect functional outcomes
- Previous use of walking aides
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
Functional Outcome Scores
Time frame: 12 months post operatively
During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes.
4 secondary outcomes
Return to work
Time frame: up to 12 months
Fracture Healing
Time frame: up to 12 months
Pain Scores
Time frame: 12 months post operatively
Post operative complications
Time frame: up to 12 months
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 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Blake W Miller, DO principal investigator
Corewell Health West
Questions about this trial
What is this clinical trial studying?
An observational study of Broken Ankle, run by Corewell Health West.
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 13 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional Outcome Scores (time frame: 12 months post operatively). 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 Sep 2023.