Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 245
- 试验地点
- 10
- 主要终点
- 24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 22 to 65 years at time of screening
- •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
- •Body Mass Index (BMI) of ≤ 35
- •Weight < 300 lbs
- •Anterior Knee Pain Score (AKPS) of ≤ 70 (0-100 scale)
- •Visual Analog Score (VAS) of ≥ 40 (0-100 scale)
- •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
排除标准
- •PCD with an Modified Outerbridge Score of 2 or less at the study knee
- •Clinical symptoms of the contralateral knee that preclude activities of daily living, stair climbing, stair descending, or require the use of an assist device
- •History of patella dislocation or instability
- •Patella alta or patella baja
- •Known TT-TG distance >20mm
- •Patients requiring simultaneous cartilage grafting procedure, cartilage transplantation, or bone marrow stimulation
- •Previous repair of a torn patellar tendon
- •Prior TTO procedure or knee joint replacement (total or partial) of the study knee
- •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
- •Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondral debridement, and loose body removal within 3 months prior to planned index procedure
- •Active infection, sepsis, osteomyelitis or history of septic arthritis in any joint
- •Rheumatoid arthritis, other forms of inflammatory joint disease or autoimmune disorder
- •History of avascular necrosis of any bone
- •History of symptomatic patellar tendonitis of intrasubstance tear
- •Insufficiency of the cruciate, collateral ligaments, or tendon which would preclude stability of the LIFT System
- •Pathologic ligamentous injury (Lachman > 1) or meniscus tearing
- •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
- •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
结局指标
主要结局
24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO.
时间窗: 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"
次要结局
- Time to Partial Weight Bearing (Recovery)(24 months)
- Time to Full Weight Bearing Without Assistive Devices (Recovery)(24 months)
- Function(24 Months)
- Patient's Reported Pain Level(24 Months)