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Recruiting NCT06423300

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

No phase Interventional Patellofemoral Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIFT Implant, Tibial Tubercle Osteotomy.
Who it may be relevant to
Registry conditions: Patellofemoral Osteoarthritis. Basic parameters: 22 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Device LIFT 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
  • Other Tibial Tubercle Osteotomy
    Tibial Tubercle Osteotomy

Primary outcome measures

  • 24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO. [Time frame: 24 months]
Secondary outcome measures (6)
  • Time to Partial Weight Bearing (Recovery) [Time frame: 24 months]
  • Time to Full Weight Bearing Without Assistive Devices (Recovery) [Time frame: 24 months]
  • Function [Time frame: 3 Months]
  • Function [Time frame: 24 Months]
  • Patient's Reported Pain Level [Time frame: 3 Months]
  • Patient's Reported Pain Level [Time frame: 24 Months]

Eligibility criteria

Inclusion criteria

  • 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
  • Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
  • Visual Analog Score (VAS) of ≥ 40 (0-100 scale)
  • 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 Confidential ZKR Orthopedics, CIP 0001 Page 11 of 55 Protocol Version: 1.0, 04JAN2024 modification, etc.) per AAOS Treatment of Osteoarthritis of the Knee; Evidence based guideline 3rd Edition 2021

Exclusion criteria

  • 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
  • Known TT-TG distance >20mm
  • Patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation
  • Previous repair of a torn patellar tendon
  • Prior TTO procedure or knee joint replacement (total or partial) of the study knee
  • Joint modifying surgery (e.g., ligament reconstruction, meniscus repair, cartilage transplantation, microfracture, etc.) in the study knee within 6 months prior to planned index procedure date
  • Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure
  • Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint
  • Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
  • History of avascular necrosis of any bone
  • History of symptomatic patellar tendonitis of intrasubstance tear
  • Insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the LIFT System
  • Pathologic ligamentous injury (Lachman > 1) or meniscus tearing
  • Clinical symptoms of the femoral-tibial joint of the study knee that preclude activities of daily living, stair climbing, stair descending, or requires the use of an assist device
  • Evidence (MRI, arthroscopy, etc.) of Modified Outerbridge Grade 4 degenerative arthritis in the femoral-tibial joint of the study knee that potentially explains patient symptoms

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Horizon Clinical Research — La Mesa
  • Hospital for Special Surgery — New York
  • NYU Langone Health — New York
  • Ohio State University - Jameson Crane Sports Medicine Institute — Columbus
  • Oregon Health and Science University — Portland

Identifiers

NCT: NCT06423300 · CIP0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗