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).
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
Body Mass Index (BMI) of ≤ 35
Weight < 300 lbs
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
Parallel
LIFT Implant
DeviceThe 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
Tibial Tubercle Osteotomy
Other interventionTibial Tubercle Osteotomy
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
The Composite Endpoint is comprised of the following: 1. an improvement of \>10 points from baseline in the Anterior Knee Pain Scale (AKPS) 2. Freedom from serious procedure-related adverse events leading to secondary surgical intervention (SSI). 3. As determined by x-ray or MRI: Freedom from loosening of implant, loosening of bone screws, breakage of screw or implant, migration of implant; TTO osseous non-union, partial union, delayed union, malunion in any plane, TTO screw loosening, TTO screw breakage The above 3 measures are COMBINED to produce the composite endpoint. If the subject meets all 3 outcome measures above at the 24 month mark - the outcome is listed as "non inferiority of the LIFT System as compared to TTO"
Time to Partial Weight Bearing (Recovery)
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing.
Time to Full Weight Bearing Without Assistive Devices (Recovery)
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to full weight bearing without the use of assistive devices.
Function
Superiority of the LIFT system to TTO data for: Functional Outcome: Early Functional Improvement as determined by the baseline change of the AKPS (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score.
Function
Superiority of the LIFT system to TTO data for: Functional Outcome: Late Functional Improvement as determined by the baseline change of the AKPS Score (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient Report Outcome KOOS Survery
Level of Patient Satisfaction (Patient Reported)
This outcome will determine the patient's satisfaction with the procedure based on a patient reported satisfaction questionnaire.
Willingness of Patient to Have Procedure Again (Patient Reported)
This outcome will determine the patient's willingness to repeat the LIFT procedure based on a patient reported questionnaire.
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