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Tritanium® Primary Acetabular Shell Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01063751
First received: February 4, 2010
Last updated: November 16, 2016
Last verified: November 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 ]

Enrollment: 240
Study Start Date: July 2011
Estimated Study Completion Date: November 2026
Estimated Primary Completion Date: November 2021 (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

Locations
United States, California
Mercy Medical Group
Sacramento, California, United States, 95816
Coon Joint Replacement Institute
St. Helena, California, United States, 94574
United States, Florida
Florida Medical Clinic
Tampa, Florida, United States, 33542
United States, Kentucky
Unversity of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Imperial Calcasieu Medical Group
Lake Charles, Louisiana, United States, 70601
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, New York
Syracuse Orthopedic Specialists
Syracuse, New York, United States, 13214
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
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: John Bradford, 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: November 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis
Traumatic arthritis
Avascular Necrosis

ClinicalTrials.gov processed this record on December 09, 2016