The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.
Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.
Colorado Joint Replacement
Denver, Colorado, United States
Syracuse Orthopedic Specialists
De Witt, New York, United States
Eastern Oklahoma Orthopedic Center
Tulsa, Oklahoma, United States
PENN Orthopedics
Philadelphia, Pennsylvania, United States
Device Survival
Time frame: All post-op visits until last patient enrolled reaches 2 year follow-up
Efficacy
Time frame: 6 month post-op and annually until last patient reaches 2 year follow-up
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Texas Hip and Knee
Fort Worth, Texas, United States