TerminatedPhase 1/2

Losartan to Improve Hip Microfracture

Stopped: redesigned trial using another placebo controlled drug

United States1 participantsStarted 2020-08-07

Plain-language summary

Phase I/IIA randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Underwent primary hip arthroscopy * Underwent baseline quantitative MRI at The Steadman Clinic (TSC) * Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with Bone Marrow Stimulation (BMS; i.e. microfracture) * Aged 18-60 at time of surgery * Tonnis grade 1 or less Exclusion Criteria: * Two or more cartilage lesions of grade 3 or 4 * Less than 2 mm of minimal hip joint space * Osteoarthritis or diffuse change of cartilage * Non-English speaking * Prior hip surgery on operative hip * Pre-existing bony deformity caused by previous fracture(s) * Synovial chondromatosis * Pigmented Villonodular Synovitis (PVNS) * Dysplasia (center edge angle \<20 degrees) * History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE) * Inflammatory arthritis or other arthritis caused by autoimmune disease * Patients allergic to any active or inactive ingredient of losartan * Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole. * Subjects that are currently taking losartan

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: Drug related adverse events will be monitored during the medication phase (post-op days 2-31) and orthopaedic-related health and function will be monitored for the entire study duration (18 months).

Trial details

NCT IDNCT04212650

SponsorSteadman Philippon Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-04

Results submitted2023-06-26

View on ClinicalTrials.gov More Hip Osteoarthritis trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.