Your session is about to expire
← Back to Search
Saline Lavage for Ankle Fracture
N/A
Recruiting
Led By Samuel Adams, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be older than 18 years old
Must not have
Open fracture
Subjects presenting >48 hours from the time of injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, in the or after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.
Awards & highlights
Summary
This trial will study the effects of early, percutaneous, intra-articular saline lavage on the human ankle's synovial fluid microenvironment during the acute phase following intra-articular fracture.
Who is the study for?
This trial is for adults over 18 who have a specific type of ankle fracture where the break extends into the joint surface, and are treated at Duke University Hospital within 48 hours of injury. It's not for those with open fractures, injuries older than 48 hours, or non-surgical cases.Check my eligibility
What is being tested?
The study tests if washing out the ankle joint with saline soon after an intra-articular fracture can reduce inflammation and prevent cartilage damage compared to patients who don't get this early lavage before their surgery.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort at the injection site, infection risk from introducing a needle into the joint space, and possible allergic reactions to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a broken ankle bone that extends into the joint.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a broken bone that is exposed through my skin.
Select...
I sought medical help more than 48 hours after my injury.
Select...
I am under 18 years old.
Select...
I have fractures that were treated without surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, in the or after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, in the or after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cytokines levels at specific time points after injury
Change in matrix metalloproteinase levels at specific time points after injury
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-articular saline lavageExperimental Treatment1 Intervention
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.
Group II: No intra-articular saline lavageActive Control1 Intervention
Subjects in group 2 will not undergo normal saline 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, they will undergo intra-articular injection of 10cc of 1% lidocaine without epinephrine 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline Lavage
2010
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,426 Total Patients Enrolled
Samuel Adams, MDPrincipal InvestigatorDuke Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I have a broken bone that is exposed through my skin.I sought medical help more than 48 hours after my injury.I got injured within the last 48 hours.I am under 18 years old.I have a broken ankle bone that extends into the joint.I have fractures that were treated without surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-articular saline lavage
- Group 2: No intra-articular saline lavage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger