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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652881
• Other study ID #: 21-14283
• Secondary ID: R21AR081008
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: United States Naval Medical Center, San Diego
• Contact: Benjamin M Wheatley, MD
• Phone: 619-532-5101
• Email: benjamin.m.wheatley.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Inflammation
• Osteoarthritis
• Post-Traumatic Osteoarthritis of Ankle
• Post-traumatic; Arthrosis
• Tibial Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Brooke Army Medical Center, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Adams SB, Reilly RM, Huebner JL, Kraus VB, Nettles DL. Time-Dependent Effects on Synovial Fluid Composition During the Acute Phase of Human Intra-articular Ankle Fracture. Foot Ankle Int. 2017 Oct;38(10):1055-1063. doi: 10.1177/1071100717728234. Epub 2017 Sep 11. — View Citation

Adams SB, Setton LA, Bell RD, Easley ME, Huebner JL, Stabler T, Kraus VB, Leimer EM, Olson SA, Nettles DL. Inflammatory Cytokines and Matrix Metalloproteinases in the Synovial Fluid After Intra-articular Ankle Fracture. Foot Ankle Int. 2015 Nov;36(11):1264-71. doi: 10.1177/1071100715611176. Epub 2015 Oct 8. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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	6 months