Risk stratification in primary total joint arthroplasty: the current state of knowledge.
Christian Gronbeck, Mark P Cote, Jay R Lieberman...
https://pubmed.ncbi.nlm.nih.gov/31020036Actively Recruiting
Phase Not Applicable
All Genders
Healthy Volunteers
ID05519007
Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Led by Northwell Health · Updated on 2025-05-23
936
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
Next Science TM
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the 90-day rate of joint infections in adults undergoing primary hip replacement surgery. This trial compares the use of Next Science No-Rinse Solution (NS) to the standard saline irrigation (SOC) to see which method better reduces post-operative joint infections. The study is a randomized, controlled clinical trial conducted at a single site with two parallel groups. Participants will be randomly assigned to one of two groups: the experimental group, where the surgical site is irrigated with NS prior to closure and suctioned at the end of treatment, or the control group, where saline irrigation is used. This treatment is applied during surgery just before closing the surgical site. Throughout the study, participants will be monitored for joint infections up to 90 days after surgery. Researchers will also assess any changes in heart rhythm (QT prolongation) within 24 hours from irrigation to closure. Participants must be available for all scheduled visits and follow study procedures, including transportation to the study site. The total study duration covers the 90-day post-operative period.
CONDITIONS
Brief Title
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adult meeting at least one high-risk health criterion such as ASA 3, BMI over 35, poorly controlled chronic diseases, active nicotine use, or age 65 or older
- Scheduled to undergo primary joint replacement surgery
- Willing and able to follow all study procedures and attend scheduled visits
- Has signed and dated informed consent form
You will not qualify if you...
- Unable to provide signed informed consent
- Unable or unwilling to comply with study procedures
- Known allergy to study products or standard care items
- Contraindications to general anesthesia
- Positive for Covid-19 at surgical screening
- Evidence of prolonged QT segment on EKG
- Belongs to a vulnerable population as defined by regulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 24 hours (from the time of irrigation to closure)
Participants undergo primary joint replacement surgery with the surgical site irrigated using either the No-Rinse Solution or saline before closure.
1 surgery visit (in-person)
Post-operative Follow-up
Duration - 90 days
Participants are monitored for infection and other outcomes following surgery.
Follow-up visits as scheduled up to 90 days post-surgery
Trial Site Locations
Total: 3 locations
1
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
3
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
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Research Team
M
Meriton Ruhani
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review.
Suneetha Ramani Moonesinghe, Michael G Mythen, Priya Das...
https://pubmed.ncbi.nlm.nih.gov/24195875Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons.
Karl Y Bilimoria, Yaoming Liu, Jennifer L Paruch...
https://pubmed.ncbi.nlm.nih.gov/24055383