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

Launched by ZKR ORTHOPEDICS INC · May 15, 2024

Keywords

ClinConnect Summary

The PELICAN study is a clinical trial designed to compare two different treatments for people suffering from knee pain caused by patellofemoral cartilage degeneration, a type of osteoarthritis. The trial is looking at the effectiveness of the Patellar LIFT System, which is an implant designed to help support the knee, versus a surgical procedure called Tibial Tubercle Osteotomy (TTO), which involves repositioning the knee's bones to relieve pressure. The study is currently recruiting participants aged 22 to 65 who have been experiencing knee pain for at least six months and have not found relief from non-surgical treatments like physical therapy or medications.

To qualify for the study, participants must meet certain criteria, such as having a specific level of cartilage damage shown on an MRI, a body mass index (BMI) of 35 or less, and a certain score indicating their level of knee pain. Throughout the trial, participants will receive either the LIFT Implant or TTO, and researchers will monitor their progress to see which treatment leads to better outcomes. If you are considering participating, it’s important to know that the study has specific eligibility requirements, and a thorough screening process will determine if you are a good fit for this research.

Gender

ALL

Eligibility criteria

• 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