Evaluation of the Patellar LIFT System for Subjects With Patellofemoral Cartilage Degeneration

Part of paid clinical trials in La Mesa, California.

Sponsor
ZKR Orthopedics Inc
Study ID
NCT06423300
Status
Recruiting
Apply to this trial

Conditions

  • Patellofemoral Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
  • Tibial Tubercle Osteotomy — OTHER
    Tibial Tubercle Osteotomy

Study Details

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).

Key Dates

Start date
Jun 19, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2031

Study Design

Enrollment
245 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group: LIFT
    Subjects receiving the LIFT implant system.
  • Active Comparator: Control Group: TTO
    Subjects receiving a Tibial Tubercle Osteotomy (TTO)

Primary Outcome Measure

24 month composite endpoint demonstrating non-inferiority of the LIFT System as compared to TTO. [ Time Frame: 24 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Horizon Clinical ResearchLa MesaCalifornia91942
Dino Subasic
[email protected]
Scott Hacker, MD (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Hannah Terry
[email protected]
Sabrina Strickland, MD (PRINCIPAL_INVESTIGATOR)
Andreas Gomoll, MD (SUB_INVESTIGATOR)
NYU Langone HealthNew YorkNew York11220
Ivanka Bhambhani
[email protected]
Alexander Golant, MD (PRINCIPAL_INVESTIGATOR)
Laith Jazwari, MD (SUB_INVESTIGATOR)
Ohio State University - Jameson Crane Sports Medicine InstituteColumbusOhio43202
Jenna DeFranco
[email protected]
David Flanigan, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Jessica Ballin
[email protected]
Dennis Crawford, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Mesa, CA

By research site
Horizon Clinical Research· La Mesa, CAHospital for Special Surgery· New York, NYNYU Langone Health· New York, NYOhio State University - Jameson Crane Sports Medicine Institute· Columbus, OHOregon Health and Science University· Portland, OR

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