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NCT06423300NARecruiting

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

ZKR Orthopedics Inc

Start Date

6/19/2024

Completion Date

9/1/2031

Summary

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).

Eligibility Criteria

Age Range: 22 years to 65 years

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

Interventions

DEVICE

LIFT Implant

OTHER

Tibial Tubercle Osteotomy

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Conditions

Patellofemoral Osteoarthritis

Locations

Horizon Clinical Research

La Mesa, California 91942

United States

Hospital for Special Surgery

New York, New York 10021

United States

NYU Langone Health

New York, New York 11220

United States

Ohio State University - Jameson Crane Sports Medicine Institute

Columbus, Ohio 43202

United States

Oregon Health and Science University

Portland, Oregon 97239

United States