Losartan to Improve Hip Microfracture

• Status: Terminated
• Trial end date: 2020-12-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steadman Philippon Research Institute
• Collaborators: Office of Naval Research (ONR); United States Department of Defense
• Treatments: Losartan

Criteria

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