NCT06108063 · Steadman Philippon Research Institute
Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
What this study is about
The purpose of this study is to evaluate the effectiveness of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
Exclusion criteria
- 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;
- Subjects 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 contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects of the study.
Where
- Vail, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2024 · Source of record for eligibility and locations