Biologically Regulated Marrow Stimulation by Blocking Fibrosis to Improve Cartilage Repair: A Randomized Double-Blind, Placebo-Controlled Study

Biologically Regulated Marrow Stimulation by Blocking Fibrosis to Improve Cartilage Repair: A Randomized Double-Blind, Placebo-Controlled Study

Principal Investigator: 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

Primary Objectives:
  • 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.

Secondary Objective:
  • Compare patient reported outcomes at 3, 6, 12, and 18 months postoperatively between patients treated with losartan + microfracture and microfracture + placebo alone.

Eligibility Criteria:

Inclusion Criteria:
Subjects will be included if all the following criteria are met:
  1. Underwent primary hip arthroscopy with Dr. Marc Philippon
  2. Underwent baseline quantitative MRI at TSC (standard hip MR)
  3. Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with BMS (microfracture)
  4. Aged 18-60 at time of surgery
  5. Tonnis grade 1 or less
Exclusion Criteria:
Subjects will be excluded if any of the following criteria are met:
  1. Two or more cartilage lesions of grade 3 or 4
  2. Less than 2 mm of minimal hip joint space
  3. Osteoarthritis or diffuse change of cartilage
  4. Non-English speaking
  5. Prior hip surgery on operative hip
  6. Pre-existing bony deformity caused by previous fracture(s)
  7. Synovial chondromatosis
  8. Pigmented Villanodular Synovitis (PVNS)
  9. Dysplasia (center edge angle <20 degrees)
  10. History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
  11. Inflammatory arthritis or other arthritis caused by autoimmune disease
  12. Patients allergic to any active or inactive ingredient of losartan
  13. Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole.
  14. Subjects that are currently taking losartan
If you would like more information about the study, please contact us at clinicaltrials@sprivail.org or 970-238-8086.
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