RECRUITING

Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

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Conditions

Knee Arthroplasty, TotalTKA Losartan Arthrofibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Quick Facts

Study Start:2024-03-06
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06108063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Planned primary total knee arthroplasty of a single knee;
  2. 2. Male or female ≥ 18 years of age;
  3. 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.
  1. 1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
  2. 2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
  3. 3. Previous knee arthroplasty on the study knee;
  4. 4. Previous infection affecting the study knee;
  5. 5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
  6. 6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
  7. 7. Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
  8. 8. Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
  9. 9. Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
  10. 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. 11. Allergic to any active or inactive ingredient of Losartan;
  12. 12. Taking medication with known adverse Losartan interaction;
  13. 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.

Contacts and Locations

Study Contact

Suzanne L Page, JD
CONTACT
970-401-8770
spage@sprivail.org
Luz Thede
CONTACT
970-409-7566
lthede@sprivail.org

Principal Investigator

Johnny Huard, PhD
PRINCIPAL_INVESTIGATOR
Steadman Philippon Research Institute
Scott Tashman, PhD
PRINCIPAL_INVESTIGATOR
Steadman Philippon Research Institute

Study Locations (Sites)

The Steadman Clinic
Vail, Colorado, 81657
United States

Collaborators and Investigators

Sponsor: Steadman Philippon Research Institute

  • Johnny Huard, PhD, PRINCIPAL_INVESTIGATOR, Steadman Philippon Research Institute
  • Scott Tashman, PhD, PRINCIPAL_INVESTIGATOR, Steadman Philippon Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • TKA Losartan Arthrofibrosis

Additional Relevant MeSH Terms

  • Knee Arthroplasty, Total