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
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