Intra Articular Ankle Fractures

Not Applicable

Terminated

Conditions: Intra-Articular Fractures

Interventions: Device: Saline Lavage
Other: No intra-articular saline lavage
Drug: Lidocaine - intra-articular injection
Other: Synovial Fluid Aspiration

Registration Number: NCT05465382

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular saline lavage	Saline Lavage	Subjects in Group 1 will then undergo saline joint lavage as follows: Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Intra-articular saline lavage	Saline Lavage	Subjects in Group 1 will then undergo saline joint lavage as follows: Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Intra-articular saline lavage	Lidocaine - intra-articular injection	Subjects in Group 1 will then undergo saline joint lavage as follows: Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
Intra-articular saline lavage	Synovial Fluid Aspiration	Subjects in Group 1 will then undergo saline joint lavage as follows: Subjects will undergo aspiration of the injured ankle joint via the standard anteromedial arthroscopy portal approach. This will be performed with sterile technique using a 16-gauge needle attached to a 10cc syringe. After synovial fluid aspiration, three 10cc syringes will be filled with 10cc of sterile 0.9% normal saline. Normal saline will be injected into the ankle joint and withdrawn from the joint via the existing anteromedial 16 gauge needle. After three rounds of lavage, 10cc of 1% lidocaine without epinephrine will be injected into the joint via the existing anteromedial 16-gauge needle. Subjects will undergo a period of soft tissue rest to allow for the resolution of soft tissue swelling. At the time of surgical fixation subjects will again undergo intra-articular aspiration of the injured ankle joint.
No intra-articular saline lavage	No intra-articular saline lavage	Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage	Lidocaine - intra-articular injection	Subjects in group 2 will not undergo normal saline lavage.
No intra-articular saline lavage	Synovial Fluid Aspiration	Subjects in group 2 will not undergo normal saline lavage.

Primary Outcome Measures

Name	Time	Method
Change in cytokines levels at specific time points after injury	baseline, in the OR after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.	Analyte concentrations will be collected during standardized aspirations at the time of emergency department presentation and at the time of surgery.
Change in matrix metalloproteinase levels at specific time points after injury	baseline, in the OR after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.	Analyte concentrations will be collected during standardized aspirations at the time of emergency department presentation and at the time of surgery.

Secondary Outcome Measures