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Angiotensin II Receptor Blocker

Losartan for Total Knee Replacement Complications

Phase 1 & 2
Recruiting
Led By Scott Tashman, PhD
Research Sponsored by Steadman Philippon Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments
Male or female ≥ 18 years of age
Must not have
Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee
Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks post-op, and 3 months post-op

Summary

This trial evaluates if taking Losartan before/after surgery can help reduce complications and improve outcomes.

Who is the study for?
This trial is for adults over 18 who are planning to have a knee replacement surgery on one knee and can consent to the study. They should not be hypotensive, pregnant, or planning pregnancy; nor should they have had previous knee replacements or surgeries planned during the study. They must not take opioids recently or certain medications like Losartan.
What is being tested?
The trial is testing if taking Losartan before and after knee replacement surgery can prevent arthrofibrosis (stiffness) and improve outcomes. Participants will either receive Losartan or a placebo without knowing which one they're getting.
What are the potential side effects?
Losartan may cause side effects such as dizziness due to low blood pressure, fatigue, light-headedness especially upon standing up quickly, swelling in legs or arms, stuffy nose, back pain, and chest pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can make my own medical decisions and agree to follow the study's requirements.
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I am 18 years old or older.
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I am scheduled for a total knee replacement on one knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My knee arthritis is due to an autoimmune disease.
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I am not planning any leg surgery other than knee replacement in the study leg.
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I do not have any conditions besides knee osteoarthritis that affect my walking or daily activities.
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I have taken opioid painkillers in the last 8 weeks and am not willing to stop during the study.
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I am taking medication that interacts badly with Losartan.
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I have had knee replacement surgery on the knee being studied.
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I am planning to have knee replacement surgery on my other knee during the study.
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I am currently taking Losartan or similar blood pressure medication, and Warfarin or a similar blood thinner.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks post-op, and 3 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks post-op, and 3 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee Range of Motion
Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum
Secondary study objectives
Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells
Incidence of Treatment-Emergent Adverse Events
Knee Extensor Isometric Strength Assessment
+4 more

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121
43%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Losartan (investigational)Experimental Treatment1 Intervention
Losartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).
Group II: Placebo (control)Placebo Group1 Intervention
Losartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan
2003
Completed Phase 4
~3000

Find a Location

Who is running the clinical trial?

Steadman Philippon Research InstituteLead Sponsor
10 Previous Clinical Trials
582 Total Patients Enrolled
Scott Tashman, PhDPrincipal InvestigatorSteadman Philippon Research Institute
1 Previous Clinical Trials
57 Total Patients Enrolled
Johnny Huard, PhDPrincipal InvestigatorSteadman Philippon Research Institute
1 Previous Clinical Trials
100 Total Patients Enrolled
~80 spots leftby Jun 2027
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