NCT06108063 Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
| NCT ID | NCT06108063 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Steadman Philippon Research Institute |
| Condition | Knee Arthroplasty, Total |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-06 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2024-03-06 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Johnny Huard, PhD
PRINCIPAL INVESTIGATOR
Steadman Philippon Research Institute
Frequently Asked Questions
Who can join the NCT06108063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Arthroplasty, Total. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06108063 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06108063 currently recruiting?
Yes, NCT06108063 is actively recruiting participants. Contact the research team at spage@sprivail.org for enrollment information.
Where is the NCT06108063 trial being conducted?
This trial is being conducted at Vail, United States.
Who is sponsoring the NCT06108063 clinical trial?
NCT06108063 is sponsored by Steadman Philippon Research Institute. The principal investigator is Johnny Huard, PhD at Steadman Philippon Research Institute. The trial plans to enroll 120 participants.