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New treatment option for Patellofemoral Osteoarthritis
Official title Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration
ClinicalTrials.gov ID: NCT06423300
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; New York, New York, United States; Columbus, Ohio, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.