Biologically Regulated Marrow Stimulation by Blocking Fibrosis to Improve Cartilage Repair: A Randomized Double-Blind, Placebo-Controlled Study
Marc Philippon, MD
This is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at The Steadman Clinic and Steadman Philippon Research Institute. This study is supported by The United States Department of Defense: Office of Naval Research. The purpose of this study is to test whether the quality of cartilage healing after hip microfracture can be improved by taking low dose of a drug commonly prescribed for high blood pressure called Losartan. At the end of the study, the research team will compare the losartan and placebo groups in terms of patient-reported outcomes and cartilage repair quality.
For additional information, please visit www.clinicaltrials.gov
and search for: NCT04212650
- Compare cartilage quality as assessed by quantitative MRI at 18 months postoperatively between patients treated with losartan and hip microfracture and hip microfracture with placebo alone; and
- Compare the occurrence of adverse events between treatment groups.
- Compare patient reported outcomes at 3, 6, 12, and 18 months postoperatively between patients treated with losartan + microfracture and microfracture + placebo alone.
Subjects will be included if all the following criteria are met:
- Underwent primary hip arthroscopy with Dr. Marc Philippon
- Underwent baseline quantitative MRI at TSC (standard hip MR)
- Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with BMS (microfracture)
- Aged 18-60 at time of surgery
- Tonnis grade 1 or less
Subjects will be excluded if any of the following criteria are met:
- 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 Villanodular 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
If you would like more information about the study, please contact us at firstname.lastname@example.org