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Recruiting Not applicable

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

NCT06423300 · tracked via the Priya Life Science USA tracker
Sponsor
ZKR Orthopedics Inc
Phase
Not applicable
Started
2024-06-19
Last updated
2025-12-11

Condition(s) studied

Patellofemoral Osteoarthritis

Investigational drug(s) / intervention(s)

LIFT ImplantTibial Tubercle Osteotomy

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

Tibial Tubercle Osteotomy: Tibial Tubercle Osteotomy

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).

Eligibility

Sex
ALL
Min age
22 Years
Max age
65 Years
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: 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

Primary outcome measure(s)

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

Trial sites (5)

FacilityCityRegionStatus
Horizon Clinical Research La Mesa California Recruiting
Hospital for Special Surgery New York New York Recruiting
NYU Langone Health New York New York Recruiting
Ohio State University - Jameson Crane Sports Medicine Institute Columbus Ohio Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06423300 on ClinicalTrials.gov ↗ ← All trials in the USA