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NCT Number: NCT06423300

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

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).

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Key information

Conditions

Patellofemoral Osteoarthritis

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Horizon Clinical Research, La Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIFT Implant

Device

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

Tibial Tubercle Osteotomy

Other

Tibial Tubercle Osteotomy

Primary outcomes

  1. 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:

    • an improvement of >10 points from baseline in the Anterior Knee Pain Scale (AKPS)
    • Freedom from serious procedure-related adverse events leading to secondary surgical intervention (SSI).
    • 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"

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

Other outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 24 months

    Patient Report Outcome KOOS Survery

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeff Halbrecht, MD

CONTACT

[email protected]

4152050496

Sharon Branch

CONTACT

[email protected]

9543033777

Sponsors and collaborators

Lead sponsor

ZKR Orthopedics Inc

Industry

Registry information

Acronym: PELICAN

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
May 21, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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