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

Last updated: January 6, 2025
Sponsor: ZKR Orthopedics Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

Tibial Tubercle Osteotomy

LIFT Implant

Clinical Study ID

NCT06423300
CIP0001
  • Ages 22-65
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients age 22 to 65 years at time of screening

  2. Anterior knee pain due to patellofemoral cartilage degeneration (PCD) with anModified 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 ofthe treatments (e.g. rest, bracing, physical therapy, targeted exercise, use ofNSAIDs, activity level reduction or Confidential ZKR Orthopedics, CIP 0001 Page 11of 55 Protocol Version: 1.0, 04JAN2024 modification, etc.) per AAOS Treatment ofOsteoarthritis of the Knee; Evidence based guideline 3rd Edition 2021

Exclusion

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 dailyliving, 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, cartilagetransplantation, 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, cartilagetransplantation, microfracture, etc.) in the study knee within 6 months prior toplanned index procedure date

  10. Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondraldebridement, 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 autoimmunedisorder

  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 precludestability 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 precludeactivities of daily living, stair climbing, stair descending, or requires the use ofan assist device

  18. Evidence (MRI, arthroscopy, etc.) of Modified Outerbridge Grade 4 degenerativearthritis in the femoral-tibial joint of the study knee that potentially explainspatient symptoms

Study Design

Total Participants: 245
Treatment Group(s): 2
Primary Treatment: Tibial Tubercle Osteotomy
Phase:
Study Start date:
June 19, 2024
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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