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

NCT05652881 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Brooke Army Medical Center

    collaborator FED

  • United States Naval Medical Center, San Diego

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05652881 on ClinicalTrials.gov