Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05652881

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

Led by United States Naval Medical Center, San Diego · Updated on 2024-05-06

40

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

United States Naval Medical Center, San Diego

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Open fractures
  • Delayed presentation greater than 72 hours post-injury
  • Associated talar body fracture
  • Presentation after initial external fixation 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Actively Recruiting

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Research Team

B

Benjamin M Wheatley, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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