Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
ZKR Orthopedics Inc
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
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
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 Confidenti…
Interventions
- DeviceLIFT Implant
The LIFT implant provides a less invasive option for treatment of patellofemoral cartilage degeneration in the knee. the LIFT implant unloads the patellofemoral joint by elevating the patellar tendon to unload the joint compartment and realign the kneecap toward healthier cartilage
- OtherTibial Tubercle Osteotomy
Tibial Tubercle Osteotomy
Locations (5)
- Horizon Clinical ResearchLa Mesa, California
- Hospital for Special SurgeryNew York, New York
- NYU Langone HealthNew York, New York
- Ohio State University - Jameson Crane Sports Medicine InstituteColumbus, Ohio
- Oregon Health and Science UniversityPortland, Oregon