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NCT05652881
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
Conditions: Post-traumatic; Arthrosis, Tibial Fractures, Post-Traumatic Osteoarthritis of Ankle
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: United States Naval Medical Center, San Diego
Summary
High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis.
Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury.
This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.
Eligibility Criteria
Inclusion Criteria:Male or female age 18 years or olderPresent with an axially unstable tibial pilon fracture requiring temporary external fixation followed by delayed definitive internal fixationAble to give informed consentExclusion Criteria:Open fracturesDelayed presentation greater than 72 hours post-injuryAssociated talar body fracturePresentation after initial ex-fix placementUnreconstructable or unsalvageable jointPreexisting ankle arthritisPrevious ankle surgeryContralateral ankle injuryAge less than 18 yearsPregnant womenIndividuals who are incarcerated
Source: ClinicalTrials.gov (NCT05652881). StuddyBuddy aggregates publicly available trial information.