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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Joint Lavage
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic; Arthrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard of care

    Intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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

    Full Information

    First Posted
    November 28, 2022
    Last Updated
    December 7, 2022
    Sponsor
    United States Naval Medical Center, San Diego
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brooke Army Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05652881
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    United States Naval Medical Center, San Diego
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Brooke Army Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic; Arthrosis, Tibial Fractures, Post-Traumatic Osteoarthritis of Ankle

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel randomized controlled trial
    Masking
    Outcomes Assessor
    Masking Description
    Cytokine analysis and radiographic assessment will be performed by a blinded assessor.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of care
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Joint Lavage
    Intervention Description
    An arthrotomy will be made at the time of temporary external fixation and 1L normal saline will be used to irrigate the ankle joint.
    Primary Outcome Measure Information:
    Title
    The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures
    Description
    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
    Title
    Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures
    Description
    We will evaluate radiographs obtained during the first 6 months to determine the presence and severity of post-traumatic arthritis.
    Time Frame
    6 months
    Title
    Effect of intraarticular lavage on range of motion following high-energy pilon fractures
    Description
    Range of motion measurements will be obtained at 3 and 6 months post-operatively
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benjamin M Wheatley, MD
    Phone
    619-532-5101
    Email
    benjamin.m.wheatley.mil@mail.mil

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    17004076
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