Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Part of paid clinical trials in Vail, Colorado.

Sponsor
Steadman Philippon Research Institute
Study ID
NCT06108063
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Knee Arthroplasty, Total

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2024
Status verified
Mar 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Steadman ClinicVailColorado81657
Suzanne L Page, JD
[email protected]
970-401-8770
Luz Thede
[email protected]
970-409-7566
Raymond Kim, MD (PRINCIPAL_INVESTIGATOR)

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The Steadman Clinic· Vail, CO

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