Tritanium® Primary Acetabular Shell Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01063751
First received: February 4, 2010
Last updated: April 15, 2016
Last verified: April 2016
  Purpose

This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the X3® polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert as the bearing surface.

The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.


Condition Intervention
Arthroplasty, Replacement, Hip
Device: Tritanium® Primary Acetabular Shell

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Tritanium® Acetabular Shell

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Absence of acetabular revision [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of Screw Fixation Usage in the Triathlon Acetabular Shell [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 1, 3, and 5 years ] [ Designated as safety issue: No ]
  • SF-12 Heath Survey Scores [ Time Frame: 1, 3, and 5 years ] [ Designated as safety issue: No ]
  • Lower Extremity Activty Scale (LEAS) Score [ Time Frame: 1, 3, and 5 years ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: 1,2,3,4, and 5 year ] [ Designated as safety issue: No ]
  • Follow-Up Questionnaire [ Time Frame: 6, 7, 8, 9, 10 ] [ Designated as safety issue: No ]
  • Acetabular Shell Radiographic Stability [ Time Frame: 6 weeks, 1, 3, 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: July 2011
Estimated Study Completion Date: July 2027
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell
Device: Tritanium® Primary Acetabular Shell
Tritanium® Primary Acetabular Shell in total hip replacement.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
  • B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
  • C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
  • D. Patient is a candidate for a primary cementless total hip replacement.
  • E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  • F. Patient has a Body Mass Index (BMI) ≥ 40.
  • G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
  • H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
  • J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
  • K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
  • L. Patient has a known sensitivity to device materials.
  • M. 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: NCT01063751

Contacts
Contact: Danielle Campbell 201-831-5498 danielle.campbell@stryker.com
Contact: Emily Valentino 201-831-5492 emily.valentino@stryker.com

Locations
United States, California
Mercy Medical Group Active, not recruiting
Sacramento, California, United States, 95816
Coon Joint Replacement Institute Recruiting
St. Helena, California, United States, 94574
Contact: Jennifer DeBattista    707-967-5959    Jennifer.debattista@ah.org   
Principal Investigator: John Diana, MD         
United States, Florida
Florida Medical Clinic Recruiting
Tampa, Florida, United States, 33542
Contact: Kathy Border    813-780-1555    kborder@floridamedicalclinic.com   
Principal Investigator: Stephen Raterman, MD         
Sub-Investigator: Gerald Alexander, MD         
United States, Kentucky
New Lexington Clinic Recruiting
Lexington, Kentucky, United States, 40504
Contact: Cale Jacobs    859-258-8238    cjaco@lexclin.com   
Principal Investigator: Tharun Karthikeyan, MD         
Unversity of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: April Evans    859-217-6740    April.evans@uky.edu   
Principal Investigator: Stephen Duncan, MD         
United States, Louisiana
Imperial Calcasieu Medical Group Active, not recruiting
Lake Charles, Louisiana, United States, 70601
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
United States, Massachusetts
New England Baptist Hospital Withdrawn
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
Syracuse Orthopedic Specialists Active, not recruiting
Syracuse, New York, United States, 13214
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kaitlin Healy    919-966-5495    kaitlin.healy@med.unc.edu   
Contact: Chad Helgeson    919-966-9718    chad_helgeson@med.unc.edu   
Principal Investigator: Dan Del Gaizo, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jennifer Eicher    304-285-7445    jeicher@hsc.wvu.edu   
Principal Investigator: Brock Lindsey, MD         
Sub-Investigator: Matthew Dietz, MD         
Sub-Investigator: Benjamin Frye, MD         
Sub-Investigator: Adam Klein, MD         
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: Timothy H Izant, MD Crouse Hospital
Principal Investigator: John Noble, MD Christus St. Patrick Hospital
Principal Investigator: Ron James, MD Mercy General Hospital
Principal Investigator: Ian Dickey, MD Eastern Maine Medical Center
Principal Investigator: Dan Del Gaizo, MD University of North Carolina
Principal Investigator: John Diana, MD St. Helena Hospital
Principal Investigator: Daniel Ward, MD New England Baptist
Principal Investigator: Tharun Karthikeyan, MD St. Joseph Hospital Health Center
Principal Investigator: Stephen Duncan, MD University of Kentucky Hospital
Principal Investigator: Brock Lindsey, MD West Virginia University Hospital
Principal Investigator: Stephen Raterman, MD Florida Hospital Wesley Chapel
  More Information

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01063751     History of Changes
Other Study ID Numbers: 69 
Study First Received: February 4, 2010
Last Updated: April 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis
Traumatic arthritis
Avascular Necrosis

ClinicalTrials.gov processed this record on August 28, 2016