Clinical trial NCT05465382: Intra Articular Ankle Fractures
Official title: The Effect of Early Saline Lavage on Synovial Fluid Composition Following Human Intra-Articular Ankle Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intra-Articular Fractures
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult subjects (over 18 years of age)
* Must be treated at Duke University Hospital Emergency Department
* Intra-articular fracture of the ankle joint (any fracture of the fibula or tibia in which the fracture line(s) exit into the cartilage surface of the ankle joint)
* Subjects presenting between 0-48 hours from the time of injury

Exclusion Criteria:

* Age \< 18 y.o.
* Open fracture
* Nonoperatively treated fractures
* Subjects presenting \>48 hours from the time of injury

Primary outcomes:
measure: Change in cytokines levels at specific time points after injury
timeFrame: baseline, in the OR after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.
measure: Change in matrix metalloproteinase levels at specific time points after injury
timeFrame: baseline, in the OR after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Samuel Adams, MD
role: PRINCIPAL_INVESTIGATOR
References:
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