Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fract… (NCT05465382) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Early Saline Lavage on Synovial Fluid Composition Following Intra Articular Ankle Fractures
Stopped: Low accrual
United States41 participantsStarted 2022-07-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cytokine Levels at Specific Time Points After Injury
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury
2
Change in CTX-II (C-telopeptide of Type II Collagen) Level at Specific Time Points After Injury
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury
3
Change in MMP (Matrix Metalloproteinase) Levels at Specific Time Points After Injury
Timeframe: Baseline (within 24 hours of injury), 1 to 2 weeks post-injury