Patellofemoral Osteoarthritis
Conditions
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).
Interventions
DEVICELIFT 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
Sponsors
ZKR Orthopedics Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Full Weight Bearing Without Assistive Devices (Recovery) | 24 months | Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to full weight bearing without the use of assistive devices. |
| Time to Partial Weight Bearing (Recovery) | 24 months | Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing. |
| Function | 3 Months | Superiority of the LIFT system to TTO data for: Functional Outcome: Early Functional Improvement as determined by the baseline change of the AKPS (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score. |
| Patient's Reported Pain Level | 3 Months | Superiority of the LIFT system to TTO data for: Early pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Willingness of Patient to Have Procedure Again (Patient Reported) | 24 months | This outcome will determine the patient's willingness to repeat the LIFT procedure based on a patient reported questionnaire. |
| Level of Patient Satisfaction (Patient Reported) | 24 months | This outcome will determine the patient's satisfaction with the procedure based on a patient reported satisfaction questionnaire. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 24 months | Patient Report Outcome KOOS Survery |
Countries
United States
Contacts
Primary ContactSharon Branch
Backup ContactJeff Halbrecht, MD
Outcome results
None listed