Losartan Use to Mitigate Arthrofibrosis Following Total J... | NCT06333522

Studies
Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty

NCT06333522

Sponsor

NYU Langone Health

Status

Withdrawn

Last Update Posted

Sep 23, 2024Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Arthrofibrosis of Knee

Interventions

Losartan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study team unable to identify method for approval of the medication as standard of care and compounded.

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Mar 21, 2024

First Submission Date that Met QC Criteria

Mar 21, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2024

Last Update Posted Date

Sep 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Losartan	Drug	Patients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.	Losartan cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in range of motion		Baseline, Day 90
Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty		Day 90

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joshua Rozell, MD	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health		New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019808	Losartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided