- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05157464
Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty
November 28, 2023 updated by: NYU Langone Health
Recent research has focused on methods to mitigate scar tissue formation and arthrofibrosis following surgery in hopes that patients may attain maximal range of motion goals, avoid manipulation and secondary surgery (i.e.
revision arthroplasty), and improve their function.
The synovial fluid milieu has also highlighted the role of local biochemical markers that may be implicated in the development of arthrofibrosis.
Losartan is an angiotensin receptor blocker with inhibitory effects on transforming growth factor beta (TGF-b), largely implicated in tissue repair and fibrosis by way of SMAD protein signaling suppression, and has been used in orthopaedic sports medicine to prevent stiffness following hip arthroscopy.
To date, this has not commonly been used at NYU Langone in orthopedic surgery.
The purpose of this study is to evaluate the efficacy of losartan use pre- and post-operatively on range of motion and the incidence of manipulation under anesthesia following total knee arthroplasty.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
- Any contraindications to Losartan
- Revision surgery
- Surgery for fracture, infection, or malignancy
- Patients with a diagnosis of post-traumatic arthritis
- Bilateral, simultaneous surgery
- Patients already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan Group
|
Patients in this group will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.
Losartan is an Angiotensin II Receptor Blocker currently used in the treatment of hypertension.
|
No Intervention: Control Group
No additional steps in management are required for the control arm of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-Operative Range of Motion (ROM)
Time Frame: 90 days post-surgery
|
ROM will be reported as the degree of knee flexion.
|
90 days post-surgery
|
Post-Operative Rate of Manipulation under Anesthesia (MUA)
Time Frame: 90 days post-surgery
|
Rate of MUA will be reported as percentage of participants that require MUA.
|
90 days post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joshua Rozell, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
December 2, 2021
First Submitted That Met QC Criteria
December 2, 2021
First Posted (Actual)
December 15, 2021
Study Record Updates
Last Update Posted (Actual)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-00823
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
IPD Sharing 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.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access upon reasonable request.
Requests should be directed to daniel.waren@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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