Comparing infection rates after hip replacement using a special solution versus saline
Official title: Clinical Evaluation of the Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
Run by Northwell Health · NCT05519007 · Data updated 2026-11-12
This study is testing if a special solution can lower the risk of joint infections after hip replacement surgery compared to regular saline.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 936 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Manhasset, New York and 2 other locations) |
| Status | Recruiting |
| Started | September 26, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 23, 2025 |
| Trial ID | NCT05519007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study include adults scheduled for primary hip replacement who have specific comorbidities or risk factors such as obesity, age over 65, or poorly controlled chronic conditions.
✕Probably not a fit
Patients who are not undergoing hip replacement surgery or do not meet the inclusion criteria related to health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is designed to evaluate the effectiveness of Next Science No-Rinse Solution in reducing the rate of joint infections within 90 days following primary hip replacement surgery. It is a prospective, single-site, double-arm, parallel, interventional, randomized, controlled trial comparing the infection rates between patients receiving the No-Rinse Solution and those receiving standard saline irrigation. The goal is to determine if the No-Rinse Solution leads to a significant reduction in post-operative joint infections compared to the standard of care.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of joint infections after hip replacement surgeries, improving patient outcomes.
How similar studies have gone: While this specific approach is novel, similar studies have shown promise in reducing infection rates with alternative irrigation solutions in surgical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Adult that meets at least one of the below criteria at time of screening:
* American Society of Anesthesiologists (ASA) 3 2
* BMI \>35
* Patient with functional limitations as a result of disease1:
* Poorly treated hypertension
* Poorly treated diabetes
* Chronic renal failure
* Bronchospastic disease
* Disease with intermittent exacerbations
* Stable angina
* Implanted pacemaker
* Known history as an active nicotine use (smoker)
* Known history of uncontrolled diabetes mellitus (HgbA1C \> 7.0)
* Known history of end stage organ disease
* Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
* Known history of current active cancer treatment (chemotherapy)
* Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
* Charleston Comorbidity Score \> 2
* Elixhauser Score \>11
* Age 65 or older
2. Subject is scheduled to primary joint replacement.
3. Subject is willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study.
4. Subject has understood, signed, and dated the informed consent form.
Exclusion Criteria:
1. Unable to provide signed and dated informed consent.
2. Unable or unwilling to comply with all study-related procedures.
3. Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
4. Subject has contraindications to general anesthesia
5. Any subject positive for Covid-19 virus at time of surgical screening
6. Subjects have evidence of prolonged QT segment, per EKG.
7. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Where it's running
-
North Shore University Hospital
Manhasset, New York, United States Recruiting -
Long Island Jewish Medical Center
New Hyde Park, New York, United States Recruiting -
Lenox Hill Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Giles Scuderi — Northwell Health
- Study coordinator: Meriton Ruhani
- Email: ruhanimeriton@gmail.com
- Phone: (212)434-4724
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oral antibiotics for treating bone and joint infections in children
This study is testing if giving oral antibiotics first can effectively and safely treat uncomplicated bone and joint infections in children and teens aged 3 months to 17 years.
-
Comparing two types of spacers for treating knee joint infections
This study is testing which type of spacer works better for treating knee joint infections in patients who have had knee replacement surgery.
-
Using alpha-defensin and synovial proteins to diagnose pediatric septic arthritis
This study is testing if certain proteins in joint fluid can help doctors better diagnose septic arthritis in children who might have joint infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.