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ZKR Orthopedics received Investigational Device Exemption (IDE) approval from FDA for a multicenter prospective clinical trial using the LIFT implant.
The PELICAN trial is designed as a prospective, propensity matched non-inferiority trial which will enroll approximately 245 patients at 24 sites in the U.S. and Europe. The treatment cohort will evaluate performance of the LIFT implant in patients suffering from later stage cartilage degeneration of the patellofemoral compartment of the knee. These results will be compared to a control group consisting of similar patients receiving a tibial tubercle osteotomy. The primary composite endpoint consists of relevant patient-reported outcomes, a safety evaluation and radiographic confirmation. Both arms will collect data on secondary endpoints including pain, function and speed of recovery. A rigorous imaging assessment will provide clinicians with a thorough evaluation of tendon safety.
As part of its PELICAN IDE application, ZKR Orthopedics reported the following data from its first in-human trial which evaluated the safety and efficacy of the LIFT implant in 18 patellofemoral cartilage degeneration patients enrolled in Warsaw, Poland and followed for 24 months.
- Overall reduction in patient reported pain from 68.6 at baseline to 26.2 at 24 months (62%) as measured by the Visual Analog Scale
- Overall improvement in patient reported function from 55.3 at baseline to 71.0 at 24 months (28%) as measured by the Anterior Knee Pain Scale also known as the Kujala Scale
- No patients progressed to partial or total knee replacement
- There was no evidence of Patellar tendon necrosis or tendon structural damage
“The evidence provided by our first in human trial combined with the data from our pre-clinical work was sufficient to allow FDA to grant authorization to enroll the pivotal trial. We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use,” commented David Cash, CEO of ZKR Orthopedics. “The IDE approval, combined with our previously obtained Breakthrough Device Designation, positions the company to increase awareness of the unmet need in the patellofemoral cartilage degeneration patient population.”
Source: ZKR Orthopedics, Inc.
ZKR Orthopedics received Investigational Device Exemption (IDE) approval from FDA for a multicenter prospective clinical trial using the LIFT implant.
The PELICAN trial is designed as a prospective, propensity matched non-inferiority trial which will enroll approximately 245 patients at 24 sites in the U.S. and Europe. The treatment cohort...
ZKR Orthopedics received Investigational Device Exemption (IDE) approval from FDA for a multicenter prospective clinical trial using the LIFT implant.
The PELICAN trial is designed as a prospective, propensity matched non-inferiority trial which will enroll approximately 245 patients at 24 sites in the U.S. and Europe. The treatment cohort will evaluate performance of the LIFT implant in patients suffering from later stage cartilage degeneration of the patellofemoral compartment of the knee. These results will be compared to a control group consisting of similar patients receiving a tibial tubercle osteotomy. The primary composite endpoint consists of relevant patient-reported outcomes, a safety evaluation and radiographic confirmation. Both arms will collect data on secondary endpoints including pain, function and speed of recovery. A rigorous imaging assessment will provide clinicians with a thorough evaluation of tendon safety.
As part of its PELICAN IDE application, ZKR Orthopedics reported the following data from its first in-human trial which evaluated the safety and efficacy of the LIFT implant in 18 patellofemoral cartilage degeneration patients enrolled in Warsaw, Poland and followed for 24 months.
- Overall reduction in patient reported pain from 68.6 at baseline to 26.2 at 24 months (62%) as measured by the Visual Analog Scale
- Overall improvement in patient reported function from 55.3 at baseline to 71.0 at 24 months (28%) as measured by the Anterior Knee Pain Scale also known as the Kujala Scale
- No patients progressed to partial or total knee replacement
- There was no evidence of Patellar tendon necrosis or tendon structural damage
“The evidence provided by our first in human trial combined with the data from our pre-clinical work was sufficient to allow FDA to grant authorization to enroll the pivotal trial. We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use,” commented David Cash, CEO of ZKR Orthopedics. “The IDE approval, combined with our previously obtained Breakthrough Device Designation, positions the company to increase awareness of the unmet need in the patellofemoral cartilage degeneration patient population.”
Source: ZKR Orthopedics, Inc.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
