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Secur-Fit Advanced Outcomes Study

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01917929
First received: June 24, 2013
Last updated: May 26, 2017
Last verified: May 2017
  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: December 2027
Estimated Primary Completion Date: December 2022 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917929

Contacts
Contact: Alice Cruz 201-831-5859 alice.cruz@stryker.com
Contact: Alana Levine 201-831-5492 alana.levine@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: Alberto Rodrigues    609-896-0444 ext 2312    arodriques@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   
Contact: Richard Dalaba, PA    518-453-9088    richandjoy@earthlink.net   
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: James Gotoff    570-271-5555 ext 52701    jrgotoff@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
Study First Received: June 24, 2013
Last Updated: May 26, 2017

Keywords provided by Stryker Orthopaedics:
[E04.555.110.110.110]

ClinicalTrials.gov processed this record on September 21, 2017