Clinical trial NCT05652881: Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
Official title: Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic; Arthrosis
Tibial Fractures
Post-Traumatic Osteoarthritis of Ankle
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Brooke Army Medical Center
First posted: 2022-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial
Primary purpose: PREVENTION

Brief 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.

Detailed description: High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in many series and can be upwards of 50% in more highly comminuted fracture patterns. Intraarticular fractures result in an increase in the synovial concentrations of inflammatory cytokines and matrix metalloproteinases. Animal models have demonstrated the irreversible damage a persistent hemarthrosis may have on cartilage viability suggesting that prolonged exposure to blood in this highly pro-inflammatory milieu may further exacerbate the chondral damage from the initial injury. However, the impact of these local inflammatory processes on the risk of post-traumatic arthritis and patient outcomes remain unclear.

The long-term goal of our research is to develop treatment modalities including surgical and pharmaceutical interventions to reduce the risk post-traumatic arthritis and dysfunction following intraarticular fractures. The objective of this study is to determine the effect of ankle joint lavage on the risk of post-traumatic arthritis and patient outcomes following high-energy pilon fractures. First, we will obtain synovial fluid samples from the ankle joint of patients undergoing temporary external fixation of a pilon fracture for cytokine analysis. Then, we will randomize patients to undergo standard treatment with or without ankle joint lavage at the time of external fixation. Patients will undergo repeat synovial fluid analysis at the time of definitive fixation to determine the effect of lavage on the concentration of pro-inflammatory cytokines. Last, patients will be followed for a period of six months after surgery to determine the impact on functional outcomes.

The information generated in this study will substantially add to our understanding of the pathogenesis of post-traumatic arthritis in high-energy pilon fractures.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
timeFrame: 2 years
Secondary outcomes:
measure: Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures
timeFrame: 6 months
measure: Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures
timeFrame: 6 months
measure: Effect of intraarticular lavage on range of motion following high-energy pilon fractures
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
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