An observational study in Pilon Fracture, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by University of Kansas Medical Center · Observational
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patient has underwent ORIF to repair a pilon fracture.
Patient has underwent PA/ankle fusion to repair a pilon fracture.
Ankle range of motion
Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Collected only once; from 6 months post-op up to date of death from any cause
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
Time frame: 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
Time frame: 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
Time frame: From the date of surgery up until the date of death from any cause
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University of Kansas Medical Center