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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group: LIFT | Experimental | Subjects receiving the LIFT implant system. |
|
| Control Group: TTO | Active Comparator | Subjects receiving a Tibial Tubercle Osteotomy (TTO) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFT Implant | Device | The LIFT implant provides a less invasive option for treatment of patellofemoral cartilage degeneration in the knee. the LIFT implant unloads the patellofemoral joint by elevating the patellar tendon to unload the joint compartment and realign the kneecap toward healthier cartilage |
| Measure | Description | Time Frame |
|---|---|---|
| 24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO. | The Composite Endpoint is comprised of the following:
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" | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Partial Weight Bearing (Recovery) | Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to partial weight bearing. | 24 months |
| Time to Full Weight Bearing Without Assistive Devices (Recovery) |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Patient Report Outcome KOOS Survery | 24 months |
| Level of Patient Satisfaction (Patient Reported) | This outcome will determine the patient's satisfaction with the procedure based on a patient reported satisfaction questionnaire. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Branch | Contact | 9543033777 | clinadmin@zkrorthopedics.com | |
| Jeff Halbrecht, MD | Contact | 4152050496 | jhalbrecht@zkrorthopedics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Clinical Research | Recruiting | La Mesa | California | 91942 | United States |
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| Tibial Tubercle Osteotomy | Other | Tibial Tubercle Osteotomy |
|
Superiority of the LIFT system to TTO data for the length of time it takes for a subject to return to full weight bearing without the use of assistive devices.
| 24 months |
| Function | Superiority of the LIFT system to TTO data for: Functional Outcome: Early Functional Improvement as determined by the baseline change of the AKPS (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score. | 3 Months |
| Function | Superiority of the LIFT system to TTO data for: Functional Outcome: Late Functional Improvement as determined by the baseline change of the AKPS Score (Anterior Knee Pain Scale) Score. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score. | 24 Months |
| Patient's Reported Pain Level | Superiority of the LIFT system to TTO data for: Early pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 3 months | 3 Months |
| Patient's Reported Pain Level | Superiority of the LIFT system to TTO data for: Late pain improvement as determined by a 30% or more improvement from baseline in knee pain score at 24 months | 24 Months |
| 24 months |
| Willingness of Patient to Have Procedure Again (Patient Reported) | This outcome will determine the patient's willingness to repeat the LIFT procedure based on a patient reported questionnaire. | 24 months |
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
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| NYU Langone Health | Recruiting | New York | New York | 11220 | United States |
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| Ohio State University - Jameson Crane Sports Medicine Institute | Recruiting | Columbus | Ohio | 43202 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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