The Effect of Early Saline Lavage on Synovial Fluid Composition Following Human Intra-Articular Ankle Fracture
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in Cytokine Levels at Specific Time Points After Injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 y.o.
- •Open fracture
- •Nonoperatively treated fractures
- •Subjects presenting >48 hours from the time of injury
研究组 & 干预措施
Intra-articular 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.
干预措施: Lidocaine - intra-articular injection (Drug)
Intra-articular 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.
干预措施: Synovial Fluid Aspiration (Other)
No intra-articular saline lavage
Subjects in group 2 will not undergo normal saline lavage.
干预措施: Synovial Fluid Aspiration (Other)
Intra-articular 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.
干预措施: Saline Lavage (Device)
No intra-articular saline lavage
Subjects in group 2 will not undergo normal saline lavage.
干预措施: No intra-articular saline lavage (Other)
No intra-articular saline lavage
Subjects in group 2 will not undergo normal saline lavage.
干预措施: Lidocaine - intra-articular injection (Drug)
结局指标
主要结局
Change in Cytokine Levels at Specific Time Points After Injury
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点