The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria. The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Straight femoral stem intended for cementless, press-fit application.
Tucson Orthopaedic Institute
Tucson, Arizona, United States
University of Colorado Denver
Aurora, Colorado, United States
Family Orthopedic Center
Spring Valley, Illinois, United States
Mercer Bucks Orthopaedics
Lawrenceville, New Jersey, United States
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.
Time frame: 5 years
All-cause Revision and Removal Rate
To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature.
Time frame: 10 years
Rate of Device-related Femoral Fracture
To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature.
Time frame: 30 days
Final Seating of Femoral Stem
To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating.
Time frame: Intraoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
OrthoNY - Everett Road Health Park
Albany, New York, United States
Hospital for Special Surgery
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Geisinger Orthopaedic Institute
Danville, Pennsylvania, United States