RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-06-19

Study Completion:2031-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06423300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sharon Branch

CONTACT

9543033777

clinadmin@zkrorthopedics.com

Jeff Halbrecht, MD

CONTACT

4152050496

jhalbrecht@zkrorthopedics.com

Study Locations (Sites)

Oregon Health and Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: ZKR Orthopedics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-19

Study Completion Date2031-09

Study Record Updates

Study Start Date2024-06-19

Study Completion Date2031-09

Terms related to this study

Additional Relevant MeSH Terms

Patellofemoral Osteoarthritis