Tritanium® Primary Acetabular Shell Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01063751
First received: February 4, 2010
Last updated: May 28, 2014
Last verified: May 2014
  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 revision [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of Screw Fixation Usage [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Pain, Function and Health Related Quality of Life (QOL) [ Time Frame: 1, 3, and 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2011
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: July 2020 (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
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: Michael A. Pelosi 201-831-5816 michael.pelosi@stryker.com
Contact: Danielle Campbell 201-831-5498 danielle.campbell@stryker.com

Locations
United States, California
Mercy Medical Group Recruiting
Sacramento, California, United States, 95816
Contact: Caroline Lenaerts, RN, MPH    916-733-5782    caroline.lenaerts@chw.edu   
Principal Investigator: Ron James, MD         
Coon Joint Replacement Institute Recruiting
St. Helena, California, United States, 94574
Contact: Jennifer DeBattista    707-967-5959    Jennifer.debattista@ah.org   
Contact: Karen Martin    707-967-5959    Karen.martin@ah.org   
Principal Investigator: John Diana, MD         
United States, Louisiana
Imperial Calcasieu Medical Group Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: DeAnne Winey-Ward    337-312-8405    dwiney@lcmsc.com   
Principal Investigator: John Noble, MD         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Denise Michaud    207-973-7175    dmichaud@emh.org   
Principal Investigator: Ian Dickey, MD         
United States, New York
Syracuse Orthopedic Specialists Recruiting
Syracuse, New York, United States, 13214
Contact: Pearl Tong-Ngork    315-703-3402    stong@sosbones.com   
Contact: AnnMarie Mesick    315-251-3100    amesick@sosbones.com   
Principal Investigator: Timothy H Izant, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Ann Collins    919-966-2878    ccollins@unch.edu   
Principal Investigator: Dan Del Gaizo, 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
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01063751     History of Changes
Other Study ID Numbers: 69
Study First Received: February 4, 2010
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis
Traumatic arthritis
Avascular Necrosis

ClinicalTrials.gov processed this record on October 19, 2014