Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration (NCT06423300) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
United States245 participantsStarted 2024-06-19
Plain-language 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).
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. PCD with an Modified Outerbridge Score of 2 or less at the study knee
✕. Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device
✕. History of patella dislocation or instability
✕. Patella alta or patella baja
✕. Known TT-TG distance \>20mm
What they're measuring
1
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.