Tritanium® Primary Acetabular Shell Study

This study is currently recruiting participants.
Verified November 2013 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01063751
First received: February 4, 2010
Last updated: November 12, 2013
Last verified: November 2013
  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
Hip Arthropathy
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:
  • To demonstrate, through absence of revision at 5 years postoperative, that acetabular replacement with the Tritanium® Acetabular Shell provides clinical results comparable to similar acetabular components. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study rates of screw fixation usage in Tritanium® Acetabular Shell (cluster hole) procedures and compare with those reported in the Trident® X3® Polyethylene Insert Study. [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • To compare pain, function and health related quality of life (QOL) between the Tritanium® Acetabular Shell group, the literature and the historical control group from the Trident X3 Polyethylene Insert Study. [ 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 2024
Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 Anthony 201-831-5498 danielle.anthony@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
  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: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Orthopaedics:
Osteoarthritis
Traumatic arthritis
Avascular Necrosis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014