Secur-Fit Advanced Outcomes Study

Not Applicable

Terminated

Brief Summary: The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation.
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease.
Patient is a candidate for primary total hip arthroplasty.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

Patient has previously undergone open surgical intervention on the operative hip.
Patient has a prior femoral fracture, with or without deformity, on the operative side.
Patient has an existing total hip replacement on the contralateral side.
Patient requires simultaneous bilateral total hip replacement.
Patient has a Body Mass Index (BMI) > 45.
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device.
Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Patient has a known sensitivity to device materials.
Patient is a prisoner.

Arm && Interventions

Group	Intervention	Description
Secur-Fit Advanced	Secur-Fit Advanced Hip Stem	Secur-Fit Advanced Hip Stem

Primary Outcome Measures

Name	Time	Method
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture	5 years	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.

Secondary Outcome Measures

Name	Time	Method
All-cause Revision and Removal Rate	10 years	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.
Rate of Device-related Femoral Fracture	30 days	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.
Final Seating of Femoral Stem	Intraoperative	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.

Locations (8): Family Orthopedic Center
🇺🇸
Spring Valley, Illinois, United States
Mercer Bucks Orthopaedics
🇺🇸
Lawrenceville, New Jersey, United States
OrthoNY - Everett Road Health Park
🇺🇸
Albany, New York, United States
Tucson Orthopaedic Institute
🇺🇸
Tucson, Arizona, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Geisinger Orthopaedic Institute
🇺🇸
Danville, Pennsylvania, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
University of Colorado Denver
🇺🇸
Aurora, Colorado, United States