NCT05465382

Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fractures

The Effect of Early Saline Lavage on Synovial Fluid Composition Following Human Intra-Articular Ankle Fracture

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effect of early, percutaneous, intra-articular saline lavage on the undiluted synovial fluid microenvironment during the acute phase following intra-articular fracture of the human ankle. We hypothesize that early intervention with percutaneous joint lavage in the first 0-48 hours after injury will attenuate the production of pro-inflammatory cytokines, MMP's and cartilage breakdown products compared to non-lavaged control subjects at the time of surgical fixation.

Detailed description

Saline joint lavage represents a potentially simple, low-risk and minimal-cost intervention which has not been previously studied for the purpose of reducing the post-fracture inflammatory burden in human subjects. Open joint lavage at the time of definitive surgical fixation is within the standard of care, but typically occurs greater than 10 days after injury by which time cartilage degradation has already begun. Early, saline lavage during initial presentation to the emergency department may theoretically alter the progression of the intra-articular inflammatory response by evacuating the bulk of the developing synovial-fluid fracture hematoma. The vast majority of ankle fractures present to the ER or urgent care within a day of fracture. Moreover, a large subset of these fractures require reduction (fracture setting) that is painful. It is our standard of care to perform an intra-articular lidocaine injection before reduction. We will take advantage of this standard of care needle insertion to the fractured ankle to perform saline joint lavage to diminish this early inflammatory burden. Adult patients presenting to the Duke University Hospital Emergency Department with an intra-articular fracture of the ankle joint between 0-48 hours from the time of injury will be eligible for inclusion. Patients will be randomized into one of two groups: 1) intra-articular saline lavage, vs 2) no intra-articular saline lavage. Intra-articular aspiration of synovial fluid from the injured ankle will occur both at the time of presentation to the emergency department and at the time of surgery. These synovial fluid samples will be analyzed for differences in key pro-inflammatory cytokines, matrix metalloproteinases and cartilage breakdown products to determine if early saline lavage effects the composition of the synovial fluid micro-environment.

Conditions

• Intra-Articular Fractures

Interventions

Type	Name	Description
DEVICE	Saline Lavage	Three rounds of 10cc of sterile 0.9% normal saline will be injected into the injured ankle joint and withdrawn from the joint using an anteromedial 16-gauge needle attached to a 10cc syringe.
OTHER	No intra-articular saline lavage	Subjects in group 2 will not undergo normal saline lavage.
DRUG	Lidocaine - intra-articular injection	Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
OTHER	Synovial Fluid Aspiration	Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.

Timeline

• Start date: 2022-07-22
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2022-07-19
• Last updated: 2026-04-14
• Results posted: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study