Evaluating a new implant system for knee cartilage degeneration

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

This study is testing a new knee implant to see if it can help people with cartilage damage feel less pain and move better compared to a standard surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 245 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: ZKR Orthopedics Inc (Industry-sponsored)
• Locations: 5 sites (La Mesa, California and 4 other locations)
• Trial ID: NCT06423300 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the outcomes of patients with patellofemoral cartilage degeneration treated with the LIFT Implant System against those undergoing Tibial Tubercle Osteotomy (TTO). It is a prospective, non-randomized, dual-arm, multi-center study designed to assess the effectiveness of the LIFT Implant in alleviating knee pain and improving function. Participants will be monitored for clinical outcomes over a specified period to determine the advantages of the LIFT system over traditional surgical methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 65 with significant anterior knee pain due to patellofemoral cartilage degeneration.

Not a fit: Patients with less severe cartilage degeneration or significant issues in the opposite knee may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from knee pain due to cartilage degeneration.

How similar studies have performed: Other studies have shown promising results with similar approaches, but the LIFT Implant System is a novel intervention in this context.

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

Where this trial is running

La Mesa, California and 4 other locations

• Horizon Clinical Research — La Mesa, California, United States (Recruiting)
• Hospital for Special Surgery — New York, New York, United States (Recruiting)
• NYU Langone Health — New York, New York, United States (Recruiting)
• Ohio State University - Jameson Crane Sports Medicine Institute — Columbus, Ohio, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)

Study contacts

• Study coordinator: Sharon Branch

Conditions Patellofemoral Osteoarthritis