Arthrofibrosis of KneePhase 4NCT06333522
Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
A Phase 4 study testing Losartan in people with Arthrofibrosis of Knee, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthrofibrosis of Knee
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
- Patients ≥18 years of age
- Patients have been medically cleared and scheduled for surgery
- Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.
Who cannot join
- Patients already taking Losartan will not be included in the prospective study
- Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
- Low blood pressure
- Currently taking hypertensive medication
- Revision surgery
- Surgery for fracture, infection, or malignancy
- Patients with a diagnosis of post-traumatic arthritis
- Bilateral, simultaneous surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm.
- Conditions
- Arthrofibrosis of Knee
- Being tested
- Losartan
- Keywords
- Total Knee Arthroplasty (TKA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Patients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Losartan cohort | Experimental | Patients will initiate Losartan treatment 2 weeks pre-operatively and will continue until 4 weeks post-operatively. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively. Receives: Drug: Losartan |
| Control cohort | No intervention | No additional steps in management are required for the control arm of the study. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion
Measured: Baseline, Day 90
Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Study team unable to identify method for approval of the medication as standard of care and compounded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthrofibrosis of KneeStudies of the same condition, open and under way.
- More trials run by NYU Langone 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Rozell, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333522
- Sponsor's protocol ID
- 23-00979
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Joshua.Rozell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT06333522
- Acronym / sponsor ID
- 23-00979
- Conditions
- Arthrofibrosis of Knee
- Keywords
- Total Knee Arthroplasty (TKA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study team unable to identify method for approval of the medication as standard of care and compounded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Mar 2024 (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.
The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan cohort | Experimental | Drug: LosartanPatients will initiate Losartan treatment 2 weeks pre-operatively and will continue until 4 weeks post-operatively. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively. |
| Control cohort | No intervention | –No additional steps in management are required for the control arm of the study. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
- Patients ≥18 years of age
- Patients have been medically cleared and scheduled for surgery
- Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.
Key exclusion criteria (8 listed)
- Patients already taking Losartan will not be included in the prospective study
- Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
- Low blood pressure
- Currently taking hypertensive medication
- Revision surgery
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 |
|---|---|---|
| LosartanPatients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively. | Drug | Losartan cohort |
Primary outcome
Change in range of motion
Time frame: Baseline, Day 90
Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty
Time frame: Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Joshua.Rozell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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. This study is not recruiting at the moment.
Joshua Rozell, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan in people with Arthrofibrosis of Knee, run by NYU Langone Health at 1 site 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in range of motion (time frame: Baseline, Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.