Secur-Fit Advanced Outcomes Study



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 75
Updated:10/18/2018
Start Date:August 2013
End Date:December 2028
Contact:Candice Kelly
Email:candice.kelly@stryker.com
Phone:919-972-2312

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A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem

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 success rate of the Secur-Fit Advanced femoral stem, defined as absence of stem revision
for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years
postoperative with a non-inferiority margin of 2.5%.


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.
We found this trial at
8
sites
3120 Princeton Pike
Lawrenceville, New Jersey 08648
Principal Investigator: Michael Ast, MD
Phone: 215-500-1051
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121 Everett Road
Albany, New York 12205
Principal Investigator: Frank Congiusta, MD
Phone: 518-453-9088
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Albany, NY
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Michael Dayton, M.D.
Phone: 720-281-7911
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Danville, Pennsylvania 17822
Principal Investigator: Thomas Bowen, MD
Phone: 570-271-5555
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Danville, PA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Samuel Wellman, MD
Phone: 919-668-4373
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Geoffrey Westrich, MD
Phone: 212-606-1510
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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Spring Valley, Illinois 61362
Principal Investigator: Paul Perona, MD
Phone: 815-663-8009
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Spring Valley, IL
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Tucson, Arizona 85713
Principal Investigator: Russell Cohen, MD
Phone: 520-784-6233
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Tucson, AZ
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