Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorZKR Orthopedics Inc

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • LIFT Implant
  • Tibial Tubercle Osteotomy

Treatment groups

245 Participants
are divided into 2 treatment groups

Locations

5
Horizon Clinical Research91942, La MesaCalifornia, United States
Hospital for Special Surgery10021, New YorkNew York, United States
NYU Langone Health11220, New YorkNew York, United States
Ohio State University - Jameson Crane Sports Medicine Institute43202, ColumbusOhio, United States

Sponsors and collaborators

ZKR Orthopedics Inc

Lead sponsor