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

December 4, 2025 updated by: ZKR Orthopedics Inc
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Horizon Clinical Research
        • Principal Investigator:
          • Scott Hacker, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Principal Investigator:
          • Sabrina Strickland, MD
        • Contact:
        • Sub-Investigator:
          • Andreas Gomoll, MD
      • New York, New York, United States, 11220
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Alexander Golant, MD
        • Sub-Investigator:
          • Laith Jazwari, MD
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • Ohio State University - Jameson Crane Sports Medicine Institute
        • Principal Investigator:
          • David Flanigan, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Dennis Crawford, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients age 22 to 65 years at time of screening
  2. 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
  3. Body Mass Index (BMI) of ≤ 35
  4. Weight < 300 lbs
  5. Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
  6. Visual Analog Score (VAS) of ≥ 40 (0-100 scale)
  7. 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:

  1. PCD with an Modified Outerbridge Score of 2 or less at the study knee
  2. Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device
  3. History of patella dislocation or instability
  4. Patella alta or patella baja
  5. Known TT-TG distance >20mm
  6. Patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation
  7. Previous repair of a torn patellar tendon
  8. Prior TTO procedure or knee joint replacement (total or partial) of the study knee
  9. 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
  10. Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure
  11. Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint
  12. Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
  13. History of avascular necrosis of any bone
  14. History of symptomatic patellar tendonitis of intrasubstance tear
  15. Insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the LIFT System
  16. Pathologic ligamentous injury (Lachman > 1) or meniscus tearing
  17. 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
  18. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group: LIFT
Subjects receiving the LIFT implant system.
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
Active Comparator: Control Group: TTO
Subjects receiving a Tibial Tubercle Osteotomy (TTO)
Other: Tibial Tubercle Osteotomy
Tibial Tubercle Osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
Time Frame: 24 months

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"
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Partial Weight Bearing (Recovery)
Time Frame: 24 months
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing.
24 months
Time to Full Weight Bearing Without Assistive Devices (Recovery)
Time Frame: 24 months
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.
24 months
Function
Time Frame: 3 Months

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.
3 Months
Function
Time Frame: 24 Months

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.
24 Months
Patient's Reported Pain Level
Time Frame: 3 Months

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
3 Months
Patient's Reported Pain Level
Time Frame: 24 Months

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
24 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 24 months
Patient Report Outcome KOOS Survery
24 months
Level of Patient Satisfaction (Patient Reported)
Time Frame: 24 months
This outcome will determine the patient's satisfaction with the procedure based on a patient reported satisfaction questionnaire.
24 months
Willingness of Patient to Have Procedure Again (Patient Reported)
Time Frame: 24 months
This outcome will determine the patient's willingness to repeat the LIFT procedure based on a patient reported questionnaire.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZKR Orthopedics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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