Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
The PELICAN study is a prospective, non randomized, dual arm, multi-center clinical study comparing clinical outcomes of subjects treated with the LIFT Implant System to subjects treated with Tibial Tubercle Osteotomy (TTO).
• Patients age 22 to 65 years at time of screening
• Anterior knee pain due to patellofemoral cartilage degeneration (PCD) with an Modified Outerbridge score of ≥3 as assessed by an MRI on the study knee
• Body Mass Index (BMI) of ≤ 35
• Weight \< 300 lbs
• Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
• Visual Analog Score (VAS) of ≥ 40 (0-100 scale)
• Failure of at least 6 months of non-surgical treatment defined as at least one of the treatments (e.g. rest, bracing, physical therapy, targeted exercise, use of NSAIDs, activity level reduction or Confidential ZKR Orthopedics, CIP 0001 Page 11 of 55 Protocol Version: 1.0, 04JAN2024 modification, etc.) per AAOS Treatment of Osteoarthritis of the Knee; Evidence based guideline 3rd Edition 2021