NCT06423300 · ZKR Orthopedics Inc
Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
(PELICAN)
What this study is about
The PELICAN study is a forward-looking, non randomly assigned, dual treatment group$1, multi-center clinical study comparing clinical outcomes of subjects treated with the LIFT Implant System to subjects treated with Tibial Tubercle Osteotomy (TTO).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- La Mesa, California
- New York, New York
- Columbus, Ohio
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2025 · Source of record for eligibility and locations