Phase
Condition
Osteoarthritis
Treatment
Tibial Tubercle Osteotomy
LIFT Implant
Clinical Study ID
Ages 22-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients age 22 to 65 years at time of screening
Anterior knee pain due to patellofemoral cartilage degeneration (PCD) with anModified 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 ofthe treatments (e.g. rest, bracing, physical therapy, targeted exercise, use ofNSAIDs, activity level reduction or Confidential ZKR Orthopedics, CIP 0001 Page 11of 55 Protocol Version: 1.0, 04JAN2024 modification, etc.) per AAOS Treatment ofOsteoarthritis of the Knee; Evidence based guideline 3rd Edition 2021
Exclusion
Exclusion Criteria:
PCD with an Modified Outerbridge Score of 2 or less at the study knee
Clinical symptoms of the contralateral knee that preclude activities of dailyliving, 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, cartilagetransplantation, 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, cartilagetransplantation, microfracture, etc.) in the study knee within 6 months prior toplanned index procedure date
Arthroscopic surgeries in the study knee for joint lavage, meniscectomy, chondraldebridement, 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 autoimmunedisorder
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 precludestability of the LIFT System
Pathologic ligamentous injury (Lachman > 1) or meniscus tearing
Clinical symptoms of the femoral-tibial joint of the study knee that precludeactivities of daily living, stair climbing, stair descending, or requires the use ofan assist device
Evidence (MRI, arthroscopy, etc.) of Modified Outerbridge Grade 4 degenerativearthritis in the femoral-tibial joint of the study knee that potentially explainspatient symptoms
Study Design
Connect with a study center
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
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