Status:
TERMINATED
Secur-Fit Advanced Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
21-75 years
Phase:
NA
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 applicati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2024
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT01917929
Start Date
August 15 2013
End Date
June 13 2024
Last Update
July 23 2025
Active Locations (8)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
Family Orthopedic Center
Spring Valley, Illinois, United States, 61362
4
Mercer Bucks Orthopaedics
Lawrenceville, New Jersey, United States, 08648