Recruiting
Phase 1
Phase 2

Losartan

Sponsor:

Steadman Philippon Research Institute

Code:

NCT06108063

Conditions

Knee Arthroplasty, Total

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Losartan

Placebo - Losartan

Study Details

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.

Conditions

Knee Arthroplasty, Total

Study ID

NCT06108063

Start date

Mar 6, 2024

Status verified date

Mar, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Losartan (investigational)

Losartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).

placebo comparator: Placebo (control)

Losartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).

Interventions

Losartan

12.5 mg oral Losartan taken for 28 days total (4 week postoperative).

Placebo - Losartan

Losartan appearance-matched Prosolv EasyTab SP placebo. 12.5 mg oral tablet taken for 28 days total (4 week postoperative).

Primary outcome measure

  • Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum [ Time Frame: Baseline, 6 weeks post-op, and 3 months post-op ]
  • Knee Range of Motion [ Time Frame: Baseline, 6 weeks post-op, and 3 months post-op ]

Central Contacts and Locations

Central contacts

Locations

The Steadman Clinic

Recruiting

Vail, Colorado, United States, 81657

Contacts

Principal Investigator:

Raymond Kim, MD

More Information

Sponsor

Steadman Philippon Research Institute

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Keywords

  • TKA Losartan Arthrofibrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Steadman Philippon Research Institute on 2024-03-12.