NCT06333522

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

March 21, 2024

Last Update Submit

September 20, 2024

Conditions

Arthrofibrosis of Knee

Keywords

Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (2)

  • Change in range of motion

    Baseline, Day 90

  • Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty

    Day 90

Study Arms (2)

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.

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.

Interventions

LosartanDRUG

Patients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.

Losartan cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Joshua Rozell, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 27, 2024

Study Start

July 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Joshua.Rozell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)