Pilon FractureNCT06089525
Treatment of Complex Pilon Fractures
An observational study of Pilon Fracture, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilon Fracture
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 25 Dec 2023
- 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: Individuals over the age of 18 that have undergone an ORIF or PA surgery for an acute pilon fracture at either KUMC or Emory University Hospital.
Inclusion Criteria: Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital.
Exclusion Criteria: Anyone under the age of 18 years. Pregnant women.
Trial locations and contacts
1 site in 1 country.
David Turkowitch, BS contact
United States1 site, 1 recruiting
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66103
Dave Turkowitch, BS, dturkowitch@kumc.edu
Brent Wise, MD
About this study
Official title: Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.
- Conditions
- Pilon Fracture
- Keywords
- Pilon Fracture
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 |
|---|---|---|
| Open reduction and internal fixation (ORIF) | Patient has underwent ORIF to repair a pilon fracture. | |
| Primary arthrodesis (PA; ankle fusion) | Patient has underwent PA/ankle fusion to repair a pilon fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle range of motion
Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors
Measured: Collected only once; from 6 months post-op up to date of death from any cause
Walking cadence
Steps per minute as determined by the use of the Opal Sensors
Measured: Collected only once; from 6 months post-op up to date of death from any cause
Timed up-and-go
Time it takes to stand from seated, walk 10 feet forward, turn around, and sit back down, unassisted (determined by the use of the Opal sensors).
Measured: Collected only once; from 6 months post-op up to date of death from any cause
Foot and ankle Outcome Score (FAOS)
Foot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes)
Measured: Collected only once; from 6 months post-op up to date of death from any cause
12 Item Short Form Survey (SF-12)
Patient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
Measured: Collected only once; from 6 months post-op up to date of death from any cause
Secondary outcomes (3)
Presence of infection and/or post-traumatic arthritis
Rate of patients being rehospitalized or returning for care beyond what is required due to infection or arthritis
Measured: From the date of surgery up until the date of death from any cause
Need for secondary operation
Number of patients that required follow up surgery to their initially injured ankle
Measured: From the date of surgery up until the date of death from any cause
Return to work time
Number of weeks it took for patients to return to work
Measured: From the date of surgery up until the date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start25 Aug 2023
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilon FractureStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Brent Wise, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089525
- Sponsor's protocol ID
- 00150446
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)
- ClinicalTrials.gov ID
- NCT06089525
- Acronym / sponsor ID
- 00150446
- Conditions
- Pilon Fracture
- Keywords
- Pilon Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 18 Oct 2023 (actual)
- 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.
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open reduction and internal fixation (ORIF) | – | –Patient has underwent ORIF to repair a pilon fracture. |
| Primary arthrodesis (PA; ankle fusion) | – | –Patient has underwent PA/ankle fusion to repair a pilon fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over the age of 18 that have undergone an ORIF or PA surgery for an acute pilon fracture at either KUMC or Emory University Hospital.
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
Ankle range of motion
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors
Walking cadence
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
Steps per minute as determined by the use of the Opal Sensors
Timed up-and-go
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
Time it takes to stand from seated, walk 10 feet forward, turn around, and sit back down, unassisted (determined by the use of the Opal sensors).
Foot and ankle Outcome Score (FAOS)
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
Foot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes)
12 Item Short Form Survey (SF-12)
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
Patient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
3 secondary outcomes
Presence of infection and/or post-traumatic arthritis
Time frame: From the date of surgery up until the date of death from any cause
Need for secondary operation
Time frame: From the date of surgery up until the date of death from any cause
Return to work time
Time frame: From the date of surgery up until the date of death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Related trials for Pilon Fracture
Recruiting
Talar Osteochondral Lesions With Pilon Fractures
Pilon Fractures
Recruiting
Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
Ankle Fractures, Pilon Fracture
Active, not recruitingObservational study
Inflammatory Response Following Intraarticular Fracture
Intraarticular Fracture and Post-traumatic Osteoarthritis
RecruitingPhase 4
Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
Pilon Fracture
Not yet recruitingPhase 1
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
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 Turkowitch, BS contact
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 Pilon Fracture, run by University of Kansas Medical Center 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?
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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brent Wise, MD (913-588-6164, bwise3@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle range of motion (time frame: Collected only once; from 6 months post-op up to date of death from any cause). The study lists 5 primary outcomes in all. 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 18 Oct 2023.