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NCT06423300 | RECRUITING | Patellofemoral Osteoarthritis

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

ZKR Orthopedics Inc

Brief 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).

Condition or disease

Patellofemoral Osteoarthritis

Intervention/treatment

LIFT Implant

Tibial Tubercle Osteotomy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 245 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of the Patellar LIFT System for Subjects with Patellofemoral Cartilage Degeneration
Actual Study Start Date : 2024-06-19
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2031-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluation of the Patellar LIFT System for Subjects with Patellofemoral Cartilage Degeneration

Location Details

NCT06423300

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How to Participate

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Locations

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239