LIFT Implant for Patellofemoral Osteoarthritis
(PELICAN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called the LIFT Implant System for individuals with patellofemoral cartilage degeneration, which causes pain in the front of the knee. Researchers aim to determine if this implant is more effective than the Tibial Tubercle Osteotomy (TTO) procedure. Participants will either receive the LIFT implant or undergo the TTO procedure to compare outcomes. The trial seeks participants who experience ongoing knee pain despite trying non-surgical treatments for at least six months. As an unphased trial, it offers participants the opportunity to contribute to pioneering research that could lead to new treatment options for knee pain.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research indicates that previous studies lack clear safety information about the LIFT implant system, which is being tested for knee cartilage problems. This absence means earlier research does not provide solid proof of its safety for people.
The trial phase is labeled as "Not Applicable," suggesting limited information on how well people tolerate the treatment. Typically, early-stage testing implies limited safety data on humans.
In this trial, researchers compare the LIFT implant system to a Tibial Tubercle Osteotomy (TTO), a known and used procedure. While detailed safety data for LIFT is lacking, TTO has established outcomes and risks.
Prospective participants should discuss potential risks and benefits with a healthcare provider to make an informed decision about joining this trial.12345Why are researchers excited about this trial?
Researchers are excited about the Patellar LIFT System because it offers a new approach to treating patellofemoral cartilage degeneration. Unlike standard treatments like physical therapy, injections, or surgical options such as Tibial Tubercle Osteotomy (TTO), the LIFT implant system is designed to directly address cartilage degeneration by providing mechanical support and improving joint alignment. This innovative approach could potentially enhance mobility and reduce pain more effectively than existing methods, giving patients a new hope for improved quality of life.
What evidence suggests that this trial's treatments could be effective?
Research has shown that the LIFT implant system, which participants in this trial may receive, could help treat wear and tear in the knee joint. Early results suggest that this system can reduce pain and improve knee movement by providing better support. Studies have found that patients using the LIFT system reported less pain and better knee function compared to those who tried other treatments. The LIFT system is designed to relieve pressure on the kneecap, which is important for managing joint issues. While more information is needed, early results are promising for those considering this treatment option. Meanwhile, the control group in this trial will receive a Tibial Tubercle Osteotomy (TTO), another treatment approach for knee joint issues.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the LIFT implant system or undergo Tibial Tubercle Osteotomy (TTO)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of knee pain, function, and patient satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- LIFT Implant
- Tibial Tubercle Osteotomy
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects receiving the LIFT implant system.
Subjects receiving a Tibial Tubercle Osteotomy (TTO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ZKR Orthopedics Inc
Lead Sponsor
Citations
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
The RFID is embedded inside the gel, located near the Implant patch system and is 9 mm in width and 2 mm in height. Implants with RFID are MR.
Important Safety Information
Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
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