Secur-Fit Advanced Outcomes Study

This study is currently recruiting participants.
Verified February 2014 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01917929
First received: June 24, 2013
Last updated: February 27, 2014
Last verified: February 2014
  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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause revision and removal rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Rate of femoral fracture [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 326
Study Start Date: August 2013
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2020 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917929

Contacts
Contact: Alice Cruz 201-831-5859 alice.cruz@stryker.com
Contact: Catherine Vanacore 201-831-5893 catherine.vanacore@stryker.com

Locations
United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Crystal Placencia    520-784-6430    cplacencia@tucsonortho.com   
Principal Investigator: Russell Cohen, MD         
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 York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: John Boles    212-639-9266    bolesj@hss.edu   
Principal Investigator: Geoffrey Westrich, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27703
Contact: Jennifer Friend    919-668-4373    jennifer.friend@duke.edu   
Principal Investigator: Samuel Wellman, MD         
Sponsors and Collaborators
Stryker Orthopaedics
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01917929     History of Changes
Other Study ID Numbers: 75
Study First Received: June 24, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Stryker Orthopaedics:
[E04.555.110.110.110]

ClinicalTrials.gov processed this record on April 17, 2014