Joint Lavage for High-energy Tibial Pilon Fractures

This study is looking at whether a procedure called joint lavage can help reduce inflammation in the ankle joint after a high-energy tibial pilon fracture (a break in the shin bone near the ankle). These types of fractures often lead to severe arthritis. Researchers believe that blood in the joint after an injury can cause more damage. In this study, doctors will irrigate the ankle joint with 1 liter of normal saline during surgery. They will then measure inflammatory cytokines (proteins that cause inflammation) in the joint fluid after two years to see if the lavage made a difference. You may be able to join if you are 18 or older, have an unstable tibial pilon fracture requiring temporary external fixation, and can give informed consent. The study aims to enroll 40 participants.

Study design
This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
What's involved
Participants will undergo an arthrotomy (a surgical incision into a joint) at the time of temporary external fixation, where 1 liter of normal saline will be used to irrigate the ankle joint.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, measuring inflammatory cytokines, will be assessed at 2 years after the procedure.

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NCT05652881

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

UNKNOWN
NAAges 18+InterventionalPrevention
United States Naval Medical Center, San Diego
~40 participants
Updated 2024-05-06 on ClinicalTrials.gov
What's tested:Joint Lavage

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
Measured over 2 years
Post-traumatic; Arthrosis
Tibial Fractures
Post-Traumatic Osteoarthritis of Ankle
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

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

Exclusion

Open fractures
Delayed presentation greater than 72 hours post-injury
Associated talar body fracture
Presentation after initial ex-fix placement
Unreconstructable or unsalvageable joint
Preexisting ankle arthritis
Previous ankle surgery
Contralateral ankle injury
Age less than 18 years
Pregnant women
Individuals who are incarcerated
  • The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines2 years

    The concentration of multiple pro-inflammatory cytokines will be measured in both the injured and non-injured extremity at the time of initial temporary external fixation and definitive fixation.