CClinicalTrials.gg
Sign In
RecruitingNCT06423300PELICANUpdated Dec 11, 2025

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

An interventional study of LIFT Implant and Tibial Tubercle Osteotomy in Patellofemoral Osteoarthritis, sponsored by ZKR Orthopedics Inc. Recruiting at 5 sites in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by ZKR Orthopedics Inc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
245
Allocation
Non-randomized
Ages
22 Years to 65 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Patellofemoral Osteoarthritis
03

In context

Lead sponsor

This is the only study on the registry with ZKR Orthopedics Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
245 participants (estimated)

Study arms

  • Experimental
    Treatment Group: LIFT

    Subjects receiving the LIFT implant system.

    Device: LIFT Implant

  • Active comparator
    Control Group: TTO

    Subjects receiving a Tibial Tubercle Osteotomy (TTO)

    Other: Tibial Tubercle Osteotomy

Interventions

  • DeviceLIFT 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

  • OtherTibial Tubercle Osteotomy

    Tibial Tubercle Osteotomy

06

What researchers measure

Primary outcomes

  1. 24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.

    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"

    Time frame: 24 months

Secondary outcomes

  1. Time to Partial Weight Bearing (Recovery)

    Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing.

    Time frame: 24 months

  2. Time to Full Weight Bearing Without Assistive Devices (Recovery)

    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.

    Time frame: 24 months

  3. Function

    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.

    Time frame: 3 Months

  4. Function

    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.

    Time frame: 24 Months

  5. Patient's Reported Pain Level

    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

    Time frame: 3 Months

  6. Patient's Reported Pain Level

    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

    Time frame: 24 Months

Other outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Patient Report Outcome KOOS Survery

    Time frame: 24 months

  2. Level of Patient Satisfaction (Patient Reported)

    This outcome will determine the patient's satisfaction with the procedure based on a patient reported satisfaction questionnaire.

    Time frame: 24 months

  3. Willingness of Patient to Have Procedure Again (Patient Reported)

    This outcome will determine the patient's willingness to repeat the LIFT procedure based on a patient reported questionnaire.

    Time frame: 24 months

07

Study locations

5 of 5 sites recruiting
  • Horizon Clinical Research
    La Mesa, California 91942, United States
    Recruiting
  • Hospital for Special Surgery
    New York, New York 10021, United States
    • Hannah Terry · Contact · terryh@hss.edu
    • Sabrina Strickland, MD · Principal investigator
    • Andreas Gomoll, MD · Sub investigator
    Recruiting
  • NYU Langone Health
    New York, New York 11220, United States
    Recruiting
  • Ohio State University - Jameson Crane Sports Medicine Institute
    Columbus, Ohio 43202, United States
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    • Jessica Ballin · Contact · ballin@ohsu.edu
    • Dennis Crawford, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06423300
Lead sponsor
ZKR Orthopedics Inc
Responsible party
Sponsor
First posted
May 21, 2024
Start date
Jun 19, 2024
Primary completion
Sep 2027 (estimated)
Completion
Sep 2031 (estimated)
Last update
Dec 11, 2025

Study contacts

Sharon Branch
Contact
clinadmin@zkrorthopedics.com
9543033777
Jeff Halbrecht, MD
Contact
jhalbrecht@zkrorthopedics.com
4152050496

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion