Secur-Fit Advanced Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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

Key facts

Study ID

NCT01917929

Run by

Stryker Orthopaedics

People needed

326

Starts

2013-08-15

Expected to finish

2024-06-13

Last updated by the study team

2025-07-23

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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