N/A
N=11
Platelet Rich Plasma Injection in Pilon Fractures
Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02481869 ↗Enrolled (actual)
11
Serious AEs
36.4%
Results posted
Feb 2021
Primary outcome: Primary: Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation — 54.89; 163.01; 2479.17; 2511.32 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arthrocentesis/PRP (Biological); Arthrocentesis/Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation |
54.89; 163.01; 2479.17; 2511.32; 37.87; 71.38 | — |
| PRIMARY Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF) |
0; 1 | — |
| SECONDARY Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) |
24.11; 28.96; 58.06; 48.97; 0.00; 6.60 | — |
| SECONDARY Patient Reported Outcomes (PROs) |
51.14; 41.13; 30.00; 46.50; 16.50; 1.4250 | — |
| SECONDARY Patient Reported Outcomes (PROs) |
51.14; 41.13; 30.00; 46.50; 16.50; 1.4250 | — |
| SECONDARY Patient Reported Outcomes (PROs) |
51.14; 41.13; 30.00; 46.50; 16.50; 1.4250 | — |
| SECONDARY Patient Reported Outcomes (PROs) |
51.14; 41.13; 30.00; 46.50; 16.50; 1.4250 | — |
Summary
Patients who sustain broken ankles have a very high risk of developing arthritis soon after injury (within 2 years). This arthritis can cause increased pain and a decrease level of function, especially if the injury occurs at an early age. During and shortly after ankle injury, there is an inflammatory chemical process that takes place in the ankle that can cause damage to the cartilage in the ankle joint. The investigators want to use what is called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own blood, to inject into the injured ankle to see if they can decrease the inflammation that happens after the injury and to see if they can decrease arthritis.
Eligibility Criteria
Inclusion Criteria
- Closed unilateral pilon fracture
Exclusion Criteria
- Patients who are younger than 18 years of age
- Open pilon fracture
- Patients with contralateral lower extremity injury
- Patients unable to comply with the follow-up appointments
- Patients who had previous ankle injury to the currently injured ankle
- Patients who are pregnant
- Prisoners
Data sourced from ClinicalTrials.gov (NCT02481869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.