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

NCT06423300 | Recruiting DMC FDA Device

• 1 other identifier: CIP0001
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Patellofemoral Osteoarthritis

Outcome Measures

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"

  24 months

Secondary Outcomes (6)

• Time to Partial Weight Bearing (Recovery)

  24 months

• Time to Full Weight Bearing Without Assistive Devices (Recovery)

  24 months

• Function

  3 Months

• Function

  24 Months

• Patient's Reported Pain Level

  3 Months

Other Outcomes (3)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  24 months

• Level of Patient Satisfaction (Patient Reported)

  24 months

• Willingness of Patient to Have Procedure Again (Patient Reported)

  24 months

Study Arms (2)

Treatment Group: LIFT

EXPERIMENTAL

Subjects receiving the LIFT implant system.

Device: LIFT Implant

Control Group: TTO

ACTIVE COMPARATOR

Subjects receiving a Tibial Tubercle Osteotomy (TTO)

Other: Tibial Tubercle Osteotomy

Interventions

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

Treatment Group: LIFT

Tibial Tubercle Osteotomy OTHER

Tibial Tubercle Osteotomy

Control Group: TTO

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZKR Orthopedics Inc: lead

Study Sites (5)

Horizon Clinical Research

La Mesa, California, 91942, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

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

RECRUITING

Central Study Contacts

Sharon Branch

CONTACT

9543033777; clinadmin@zkrorthopedics.com

Jeff Halbrecht, MD

CONTACT

4152050496; jhalbrecht@zkrorthopedics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 21, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)