Tritanium® Primary Acetabular Shell Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics Identifier:
First received: February 4, 2010
Last updated: June 3, 2015
Last verified: June 2015

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01063751

Contact: Danielle Campbell 201-831-5498
Contact: Lorie Gardner 201-831-5491

United States, California
Mercy Medical Group Recruiting
Sacramento, California, United States, 95816
Contact: Caroline Lenaerts, RN, MPH    916-733-5782   
Principal Investigator: Ron James, MD         
Coon Joint Replacement Institute Recruiting
St. Helena, California, United States, 94574
Contact: Jennifer DeBattista    707-967-5959   
Principal Investigator: John Diana, MD         
United States, Louisiana
Imperial Calcasieu Medical Group Active, not recruiting
Lake Charles, Louisiana, United States, 70601
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Claudine Allen    207-973-9013   
Principal Investigator: Ian Dickey, MD         
United States, Massachusetts
Longwood Orthopaedic Associates, Inc. Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Anna Lyczmanenko    617-754-6664   
Principal Investigator: Daniel Ward, MD         
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   
Contact: Christin Heverly    919 966-2878   
Principal Investigator: Dan Del Gaizo, MD         
Sponsors and Collaborators
Stryker Orthopaedics
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
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics Identifier: NCT01063751     History of Changes
Other Study ID Numbers: 69
Study First Received: February 4, 2010
Last Updated: June 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Traumatic arthritis
Avascular Necrosis processed this record on November 25, 2015