← 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
Adult subjects (over 18 years of age)
Subjects presenting between 0-48 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

Study 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 below
Select...
I am over 18 years old.
Select...
I got injured within the last 48 hours.
Select...
I have a broken ankle bone that extends into the joint.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, in the or after anesthesia is induced (generally within 24 hours of lavage), and 1 to 2 weeks post-injury. for reporting.

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
2,358 Previous Clinical Trials
3,420,010 Total Patients Enrolled
Samuel Adams, MDPrincipal InvestigatorDuke Health

Media Library

Saline Lavage Clinical Trial Eligibility Overview. Trial Name: NCT05465382 — N/A
Intra-Articular Fractures Research Study Groups: Intra-articular saline lavage, No intra-articular saline lavage
Intra-Articular Fractures Clinical Trial 2023: Saline Lavage Highlights & Side Effects. Trial Name: NCT05465382 — N/A
Saline Lavage 2023 Treatment Timeline for Medical Study. Trial Name: NCT05465382 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the sample size for this experiment?

"Affirmative. Per clinicaltrials.gov, this experiment is actively recruiting participants since its initial posting on July 22nd 2022 and most recent update on November 1st of the same year. 60 people must be enrolled from a solitary site."

Answered by AI

Are there vacancies available for patients to join this experiment?

"Agreed. As indicated on clinicaltrials.gov, this study is currently recruiting participants with the trial having first been posted on July 22nd 2022 and last updated November 1st 2022. Sixty prospective patients will be needed from a single medical site for successful completion of the research project."

Answered by AI
Recent research and studies
~7 spots leftby Jul 2024