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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
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
Tibial Tubercle Osteotomy
Horizon Clinical Research
La Mesa, California, United States
RECRUITINGHospital for Special Surgery
New York, New York, United States
RECRUITINGNYU Langone Health
New York, New York, United States
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 frame: 24 months
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 frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 3 Months
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.
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Ohio State University - Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGTime frame: 24 Months
Patient's Reported Pain Level
Superiority of the LIFT system to TTO data for: Early pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 3 months
Time frame: 3 Months
Patient's Reported Pain Level
Superiority of the LIFT system to TTO data for: Late pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 24 months
Time frame: 24 Months