Joint InfectionNCT05519007
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone
A study testing No-Rinse Solution (NS) and Saline irrigation in people with Joint Infection, run by Northwell Health at 3 sites in United States.
Trial summary
A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Joint Infection
- What is being tested?
- No-Rinse Solution (NS) and Saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
- Subject is scheduled to primary joint replacement.
- 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.
- Subject has understood, signed, and dated the informed consent form.
Who cannot join
- Unable to provide signed and dated informed consent.
- Unable or unwilling to comply with all study-related procedures.
- 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)
- Subject has contraindications to general anesthesia
- Any subject positive for Covid-19 virus at time of surgical screening
- Subjects have evidence of prolonged QT segment, per EKG.
- Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Meriton Ruhani
- Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Meriton Ruhani
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Meriton Ruhani, mruhani@northwell.edu
About this study
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
A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
- Conditions
- Joint Infection
- Being tested
- No-Rinse Solution (NS), Saline irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-Rinse Solution (NS)Other
The surgical site will be irrigated with NS prior to closure,
Saline irrigationOther
The surgical site will be irrigated with Saline
| Study group | Role | What they receive |
|---|---|---|
| The Next Science treatment | Experimental | The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time Receives: Other: No-Rinse Solution (NS) |
| Standard of Care | Active comparator | Saline irrigation Receives: Other: Saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection rate
Joint infection rate after surgery
Measured: at 90 days
Secondary outcomes (1)
QT prolongation
Incidences of QT prolongation and short-term hypocalcemia
Measured: up to 24 hours (from the time of irrigation to closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start26 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint InfectionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Next Science TM
- Responsible party
- Principal investigator, Giles Scuderi, Northwell Health
- Investigators
- Giles Scuderi, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519007
- Sponsor's protocol ID
- 21-1026
- Status last verified
- May 2025
- First submitted
- 25 Aug 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
PubMed 31020036Doyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
PubMed 24195875Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
PubMed 24055383
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05519007
- Acronym / sponsor ID
- 21-1026
- Conditions
- Joint Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 936 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Next Science TM
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Next Science treatment | Experimental | Other: No-Rinse Solution (NS)The surgical site will be irrigated with NS prior to closure, which will be suctioned at the end of the treatment time |
| Standard of Care | Active comparator | Other: Saline irrigationSaline irrigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Adult that meets at least one of the below criteria at time of screening:
- Subject is scheduled to primary joint replacement.
- 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.
- Subject has understood, signed, and dated the informed consent form.
Key exclusion criteria (7 listed)
- Unable to provide signed and dated informed consent.
- Unable or unwilling to comply with all study-related procedures.
- 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)
- Subject has contraindications to general anesthesia
- Any subject positive for Covid-19 virus at time of surgical screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-Rinse Solution (NS)The surgical site will be irrigated with NS prior to closure, | Other | The Next Science treatment |
| Saline irrigationThe surgical site will be irrigated with Saline | Other | Standard of Care |
Primary outcome
infection rate
Time frame: at 90 days
Joint infection rate after surgery
1 secondary outcome
QT prolongation
Time frame: up to 24 hours (from the time of irrigation to closure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 31020036Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
- BackgroundDoyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
- Background: PubMed 24195875Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
- Background: PubMed 24055383Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giles Scuderi principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No-Rinse Solution (NS) and Saline irrigation in people with Joint Infection, run by Northwell Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meriton Ruhani ((212)434-4724, ruhanimeriton@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rate (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519007, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.