An interventional study of Joint Lavage in Post-traumatic; Arthrosis, Tibial Fractures and Post-Traumatic Osteoarthritis of Ankle, sponsored by United States Naval Medical Center, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by United States Naval Medical Center, San Diego · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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.
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.
Procedure: Joint Lavage
An arthrotomy will be made at the time of temporary external fixation and 1L normal saline will be used to irrigate the ankle joint.
The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
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.
Time frame: 2 years
Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scores will be collected at 3 and 6 months post-operatively. The AOFAS Ankle-hindfoot score is on a scale of 0-100 with higher scores indicating better function.
Time frame: 6 months
Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures
We will evaluate radiographs obtained during the first 6 months to determine the presence and severity of post-traumatic arthritis.
Time frame: 6 months
Effect of intraarticular lavage on range of motion following high-energy pilon fractures
Range of motion measurements will be obtained at 3 and 6 months post-operatively
Time frame: 6 months
Plan to share: No
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United States Naval Medical Center, San Diego