Clinical trial NCT06423300: Evaluation of the Patellar LIFT System for Subjects with Patellofemoral Cartilage Degeneration
Official title: Evaluation of the Patellar LIFT System for Subjects with Patellofemoral Cartilage Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Osteoarthritis
Lead sponsor: ZKR Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 245
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: 24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
timeFrame: 24 months
Secondary outcomes:
measure: Time to Partial Weight Bearing (Recovery)
timeFrame: 24 months
measure: Time to Full Weight Bearing Without Assistive Devices (Recovery)
timeFrame: 24 months
measure: Function
timeFrame: 3 Months
measure: Function
timeFrame: 24 Months
measure: Patient's Reported Pain Level
timeFrame: 3 Months
measure: Patient's Reported Pain Level
timeFrame: 24 Months
Other outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 24 months
measure: Level of Patient Satisfaction (Patient Reported)
timeFrame: 24 months
measure: Willingness of Patient to Have Procedure Again (Patient Reported)
timeFrame: 24 months
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References: