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New treatment option for Knee Arthroplasty, Total
Official title Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
ClinicalTrials.gov ID: NCT06108063
What this study is testing
What is Losartan?
Losartan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for knee arthroplasty, total.
Also referred to as Losartan potassium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Planned primary total knee arthroplasty of a single knee;
- Male or female ≥ 18 years of age;
- Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with...
You likely can't join if
- Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
- Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
- Previous knee arthroplasty on the study knee;
- Previous infection affecting the study knee;
- Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
- Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
See the full eligibility criteria
- Planned primary total knee arthroplasty of a single knee;
- Male or female ≥ 18 years of age;
- 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.
- Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
- Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
- Previous knee arthroplasty on the study knee;
- Previous infection affecting the study knee;
- Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
- Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
- Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
- Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
- Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
- Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period);
- Allergic to any active or inactive ingredient of Losartan;
- Taking medication with known adverse Losartan interaction;
- people that have any medical condition, including malignancies, laboratory findings, and/or findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or...
The study team makes the final eligibility decision.
Where it's taking place
- Vail, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vail, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.