Joint lavage for treating high-energy tibial pilon fractures
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
This study is testing if washing out the ankle joint can help people with serious tibial pilon fractures recover better and reduce inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | United States Naval Medical Center, San Diego Federal |
| Locations | 1 site (Fort Sam Houston, Texas) |
| Trial ID | NCT05652881 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of joint lavage on reducing inflammation in the ankle joint following high-energy tibial pilon fractures. Patients with unstable fractures requiring temporary external fixation will be randomized to receive either standard treatment or treatment with joint lavage. The study aims to analyze synovial fluid samples for inflammatory cytokines and assess short-term patient outcomes. The ultimate goal is to develop effective interventions to lower the risk of post-traumatic arthritis and improve recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with axially unstable tibial pilon fractures requiring temporary external fixation.
Not a fit: Patients with open fractures, preexisting ankle arthritis, or those who have had previous ankle surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of post-traumatic arthritis and improve recovery outcomes for patients with high-energy tibial pilon fractures.
How similar studies have performed: While the specific approach of joint lavage in this context is novel, similar studies have shown promise in reducing inflammation and improving outcomes in other joint injuries.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fort Sam Houston, Texas
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Benjamin M Wheatley, MD
- Email: benjamin.m.wheatley.mil@mail.mil
- Phone: 619-532-5101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.