Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Male or female age 18 years or older

• Present with an axially unstable tibial pilon fracture requiring temporary external fixation followed by delayed definitive internal fixation

• Able to give informed consent

Locations
United States
Texas
Brooke Army Medical Center
RECRUITING
Fort Sam Houston
Contact Information
Primary
Benjamin M Wheatley, MD
benjamin.m.wheatley.mil@mail.mil
619-532-5101
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2025-07
Participants
Target number of participants: 40
Treatments
No_intervention: Standard of care
Standard of care treatment for axially unstable tibial pilon fracture will include temporary external fixation followed by delayed definitive fixation. Arthrocentesis of the injured and uninjured ankles will be performed at the time of initial temporary external fixation and again at the time of definitive fixation.
Experimental: Intervention
Additional intra-articular joint lavage with 1L normal saline will be performed at the time of initial temporary external fixation in addition to standard of care treatment.
Related Therapeutic Areas
Sponsors
Leads: United States Naval Medical Center, San Diego
Collaborators: Brooke Army Medical Center, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov