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Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration

RecruitingNAAges 22 Years - 65 YearsAllZKR Orthopedics Inc
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients age 22 to 65 years at time of screening 2. 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 3. Body Mass Index (BMI) of ≤ 35 4. Weight \< 300 lbs 5. Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale) 6. Visual Analog Score (VAS) of ≥ 40 (0-100 scale) 7. 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 Exclusion Criteria: 1. PCD with an Modified Outerbridge Score of 2 or less at the study knee 2. Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device 3. History of patella dislocation or instability 4. Patella alta or patella baja 5. Known TT-TG distance \>20mm 6. Patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation 7. Previous repair of a torn patellar tendon 8. Prior TTO procedure or knee joint replacement (total or partial) of the study knee 9. Joint modifying surgery (e.g., ligament reconstruction, meniscus repair, cartilage transplantation, microfracture, etc.) in the study knee within 6 months prior to planned index procedure date 10. Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure 11. Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint 12. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder 13. History of avascular necrosis of any bone 14. History of symptomatic patellar tendonitis of intrasubstance tear 15. Insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the LIFT System 16. Pathologic ligamentous injury (Lachman \> 1) or meniscus tearing 17. Clinical symptoms of the femoral-tibial joint of the study knee that preclude activities of daily living, stair climbing, stair descending, or requires the use of an assist device 18. Evidence (MRI, arthroscopy, etc.) of Modified Outerbridge Grade 4 degenerative arthritis in the femoral-tibial joint of the study knee that potentially explains patient symptoms
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What it tests

  • LIFT Implant
  • Tibial Tubercle Osteotomy
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Where

5 sites
Horizon Clinical Research
La Mesa, United States
Hospital for Special Surgery
New York, United States
NYU Langone Health
New York, United States
Ohio State University - Jameson Crane Sports Medicine Institute
Columbus, United States
Oregon Health and Science University
Portland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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