Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Launched by STEADMAN PHILIPPON RESEARCH INSTITUTE · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Losartan after total knee replacement surgery, which is also known as knee arthroplasty. The goal is to see if Losartan can help reduce or prevent a condition called arthrofibrosis, which is the stiffening of the knee joint that can occur after surgery. This stiffness can make it harder for people to recover and regain normal movement, so the researchers are looking for ways to improve recovery outcomes.

To participate in this study, individuals must be at least 18 years old and scheduled for a primary total knee replacement surgery on one knee. They should be able to give informed consent themselves, meaning they can understand the study and agree to take part in it. However, certain people are not eligible, such as those who are pregnant, have had prior knee surgeries on the same knee, or are taking specific medications that could interfere with the study. Participants can expect to take Losartan as part of their post-surgery care and will be monitored throughout the study to assess its effects on their recovery. This research is currently recruiting volunteers, and it's an important step in finding better ways to help patients heal after knee surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Planned primary total knee arthroplasty of a single knee;
• • 2. Male or female ≥ 18 years of age;
• • 3. 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:
• • 1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
• • 2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
• • 3. Previous knee arthroplasty on the study knee;
• • 4. Previous infection affecting the study knee;
• • 5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
• • 6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
• • 7. Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
• • 8. Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
• • 9. Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
• • 10. 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);
• • 11. Allergic to any active or inactive ingredient of Losartan;
• • 12. Taking medication with known adverse Losartan interaction;
• • 13. 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.