Intra-Articular Fractures
Conditions
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.
Interventions
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.
Subjects in group 2 will not undergo normal saline lavage.
Intra-articular injection of 10cc of 1% lidocaine without epinephrine via the existing anteromedial 16-gauge needle.
Aspiration of ankle joint via standard anteromedial approach. Performed using sterile technique using 16-guage needle attached to 10cc syringe.
Sponsors
Study design
Masking description
Randomization will occur by the opening of pre-prepared envelopes which will be stored in the orthopaedic resident office. Envelopes will be labeled #1-#60. Thirty envelopes will contain a note card labeled "Group 1" and Thirty envelopes will contain a note card labeled "Group 2". Envelopes will be pre-prepared by key study personnel not involved in the consent or randomization process.
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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cytokine Levels at Specific Time Points After Injury | Baseline (within 24 hours of injury), 1 to 2 weeks post-injury | Reported as the total change between baseline and 1 to 2 weeks post-injury. |
| Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After Injury | Baseline (within 24 hours of injury), 1 to 2 weeks post-injury | Reported as the total change between baseline and 1 to 2 weeks post-injury. |
| Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury | Baseline (within 24 hours of injury), 1 to 2 weeks post-injury | Reported as the total change between baseline and 1 to 2 weeks post-injury. |
Countries
United States
Contacts
Duke Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 years |
| Days from injury aspirate to surgical aspirate | 9.9 days |
| Number of fracture lines 1 | 1 Participants |
| Number of fracture lines 2 | 6 Participants |
| Number of fracture lines 3 | 4 Participants |
| Number of fracture lines 4+ | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |