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Secur-Fit Advanced Outcomes Study

This study is currently recruiting participants.
Verified November 2017 by Stryker Orthopaedics
Sponsor:
ClinicalTrials.gov Identifier:
NCT01917929
First Posted: August 7, 2013
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stryker Orthopaedics
  Purpose
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%.

Condition Intervention
Arthroplasty, Replacement, Hip Device: Secur-Fit Advanced Hip Stem

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Rate of revision for aseptic loosening or femoral fracture [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • All-cause revision and removal rate [ Time Frame: 10 years ]
  • Rate of femoral fracture [ Time Frame: 30 days ]
  • Component exposure or countersink upon final seating [ Time Frame: intraoperative ]
  • Femoral head center, femoral offset and leg-length discrepency preoperative, planned and postoperative in a subset of cases [ Time Frame: preop, 6 weeks ]

Estimated Enrollment: 326
Study Start Date: August 2013
Estimated Study Completion Date: February 2028
Estimated Primary Completion Date: February 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Secur-Fit Advanced
Secur-Fit Advanced Hip Stem
Device: Secur-Fit Advanced Hip Stem
Straight femoral stem intended for cementless, press-fit application.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917929


Contacts
Contact: Candice Kelly 919-972-2312 candice.kelly@stryker.com

Locations
United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Annie Phinizy    520-784-6141    aphinizy@tucsonortho.com   
Principal Investigator: Russell Cohen, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Frank Somoza    720-281-7911    frank.somoza@ucdenver.edu   
Principal Investigator: Michael Dayton, M.D.         
Sub-Investigator: Craig Hogan, M.D.         
United States, Illinois
Family Orthopedic Center Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Colette Andreoni    815-663-8009    CAndreoni@aboutsmh.org   
Principal Investigator: Paul Perona, MD         
United States, New Jersey
Mercer Bucks Orthopaedics Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Jenny Somouan    215-500-1051    jsomouan@mbortho.com   
Principal Investigator: Michael Ast, MD         
United States, New York
OrthoNY - Everett Road Health Park Recruiting
Albany, New York, United States, 12205
Contact: Stephanie McCann    518-453-9088    smccann@orthony.com   
Principal Investigator: Frank Congiusta, MD         
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Ahava Muskat    212-606-1510    muskata@hss.edu   
Principal Investigator: Geoffrey Westrich, MD         
United States, North Carolina
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27703
United States, Pennsylvania
Geisinger Orthopaedic Institute Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Kenneth Sams    570-271-5555 ext 56821    kbsams@geisinger.edu   
Principal Investigator: Thomas Bowen, MD         
Sub-Investigator: James Murphy, MD         
Sponsors and Collaborators
Stryker Orthopaedics
  More Information

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01917929     History of Changes
Other Study ID Numbers: 75
First Submitted: June 24, 2013
First Posted: August 7, 2013
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by Stryker Orthopaedics:
[E04.555.110.110.110]