Recruiting

Joint Lavage

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT05652881

Conditions

Post-traumatic; Arthrosis

Tibial Fractures

Post-Traumatic Osteoarthritis of Ankle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Joint Lavage

Study Details

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

Study ID

NCT05652881

Start date

Jan 15, 2023

Status verified date

May, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of care

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.

experimental: Intervention

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.

Interventions

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.

Primary outcome measure

  • The effect of intraarticular lavage on the synovial concentration of inflammatory cytokines [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Benjamin M Wheatley, MD

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

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Lizabeth Summerfiled

210-848-9654LSummerfield@hjf.org

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

May 6, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2024-05-06.