Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
NCT06423300

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

Led by ZKR Orthopedics Inc · Updated on 2025-12-11

245

Participants Needed

5

Research Sites

375 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients age 22 to 65 years at time of screening
  • Anterior knee pain due to patellofemoral cartilage degeneration with a Modified Outerbridge score of 653 as assessed by MRI
  • Body Mass Index (BMI) of 64 35
  • Weight less than 300 lbs
  • Anterior Knee Pain Score (AKPS) of 64 70 on a 0-100 scale
  • Visual Analog Score (VAS) of 65 40 on a 0-100 scale
  • Failure of at least 6 months of non-surgical treatment including rest, bracing, physical therapy, targeted exercise, NSAIDs, activity reduction, or modification
Not Eligible

You will not qualify if you...

  • Patellofemoral cartilage degeneration with a Modified Outerbridge Score of 2 or less at the study knee
  • Clinical symptoms in the opposite knee that prevent daily activities, stair climbing or require assistive devices
  • History of patella dislocation or instability
  • Patella alta or patella baja
  • Known tibial tubercle-trochlear groove (TT-TG) distance greater than 20mm
  • Need for simultaneous cartilage grafting, transplantation, or bone marrow stimulation
  • Previous repair of a torn patellar tendon
  • Prior tibial tubercle osteotomy or knee joint replacement on the study knee
  • Joint modifying surgery in the study knee within 6 months before planned procedure
  • Arthroscopic surgeries in the study knee within 3 months before planned procedure
  • Active infection, sepsis, osteomyelitis, or history of septic arthritis in any joint
  • Rheumatoid arthritis, other inflammatory joint diseases, or autoimmune disorders
  • History of avascular necrosis of any bone
  • History of symptomatic patellar tendonitis or intrasubstance tear
  • Insufficient cruciate or collateral ligaments or tendon instability preventing LIFT System use
  • Pathologic ligament injury or meniscus tearing
  • Clinical symptoms in the femoral-tibial joint of the study knee that prevent daily activities, stair climbing or require assistive devices
  • Evidence of Grade 4 degenerative arthritis in the femoral-tibial joint explaining symptoms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Horizon Clinical Research

La Mesa, California, United States, 91942

Actively Recruiting

2

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

3

NYU Langone Health

New York, New York, United States, 11220

Actively Recruiting

4

Ohio State University - Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States, 43202

Actively Recruiting

5

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

S

Sharon Branch

CONTACT

J

Jeff Halbrecht, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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