Tritanium® Primary Acetabular Shell Study - Full Text View

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:

MedlinePlus related topics: Joint Disorders

U.S. FDA Resources

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
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: Jenny Williams 919-966-2878 jbradford@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:	April 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 June 18, 2013