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

NCT05652881 | Recruiting DMC

• 2 other identifiers: 21-14283R21AR081008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effect of intraarticular lavage on functional outcomes following high-energy pilon fractures

  6 months

• Effect of intraarticular lavage on radiographic outcomes following high-energy pilon fractures

  6 months

• Effect of intraarticular lavage on range of motion following high-energy pilon fractures

  6 months

Study Arms (2)

Standard of care

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Joint Lavage PROCEDURE

An arthrotomy will be made at the time of temporary external fixation and 1L normal saline will be used to irrigate the ankle joint.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Brooke Army Medical Center: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Osteoarthritis; Tibial Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Benjamin M Wheatley, MD

CONTACT

619-532-5101; benjamin.m.wheatley.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cytokine analysis and radiographic assessment will be performed by a blinded assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 15, 2022
• Study Start: January 15, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)