Post-Approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System - Full Text View

Sponsored by:	DePuy Orthopaedics
Information provided by:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00546598

Purpose

This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.

Condition	Intervention	Phase
Non-Inflammatory Joint Disease Osteoarthritis Avascular Necrosis Congenital Hip Dysplasia Post-Traumatic Arthritis	Device: Total hip replacement/arthroplasty Device: Hip replacement/arthroplasty	Phase IV

MedlinePlus related topics: Joint Disorders Osteoarthritis Osteonecrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-Approval Study

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:

Hip function (using Harris Hip Score) [ Time Frame: 6 weeks, 6 months and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Study subject SF-12 health survey [ Time Frame: 1, 2 ,3, 4 and 5 years ] [ Designated as safety issue: No ]
SF-12 Health survey and Subject Outcomes Questionnaire [ Time Frame: 6, 7, 8, 9 and 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A	Device: Total hip replacement/arthroplasty Hip replacement Device: Hip replacement/arthroplasty Hip replacement

Detailed Description:

This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase.

The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of:

a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Skeletally mature
Provide informed consent
Sufficient acetabular and femoral bone stock to seat the prosthesis
Willing and able to return for follow-up as specified by the study protocol
Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12)
Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.

Exclusion Criteria:

Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc.
Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc.
Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation.
Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant.
Morbid obesity
Involvement in high levels of activity or participation in active sports
Involvement in heavy manual labor employment
Increased likelihood of falls due to concomitant illnesses or impairment
Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser
Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant
Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease)
Known presence of active metastatic or neoplastic disease
Known allergic reactions to implant materials (e.g. ceramic, metal)
Known history of tissue reactions to implant corrosion or implant wear debris
Disabilities of other joints that impedes evaluation (e.g. knees, ankles)
Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.)
Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546598

Contacts

Contact: Barry Sisson, MBA

574-372-7156

BSisson@its.jnj.com

Locations

United States, Colorado
MERIC	Withdrawn
Colorado Springs, Colorado, United States, 80907
Memorial Health System	Withdrawn
Colorado Springs, Colorado, United States, 80909
United States, Georgia
Northside Hospital	Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Memorial Hospital	Recruiting
Springfield, Illinois, United States, 62781
St. John's Hospital	Recruiting
Springfield, Illinois, United States, 62781
United States, Ohio
Flower Hospital	Active, not recruiting
Sylvania, Ohio, United States, 43560
St. Luke's Hospital	Active, not recruiting
Maumee, Ohio, United States, 43537
Fairview Hospital	Active, not recruiting
Cleveland, Ohio, United States, 44111
United States, Oregon
Rogue Valley Medical Center	Withdrawn
Medford, Oregon, United States, 97504

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Study Director:

Barry Sisson, MBA

DePuy Orthopaedics, Inc.

More Information

No publications provided

Responsible Party:	DePuy Orthopaedics, Inc. ( Barry Sisson, MBA )
Study ID Numbers:	05024
Study First Received:	October 17, 2007
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00546598 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:

Total hip replacement, Total hip arthroplasty

Study placed in the following topic categories:

Osteonecrosis
Hip Dislocation
Osteoarthritis
Dislocations
Joint Diseases
Rheumatic Diseases
Bone Diseases

Musculoskeletal Abnormalities
Necrosis
Musculoskeletal Diseases
Arthritis
Hip Dysplasia
Congenital Abnormalities
Hip Dislocation, Congenital

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Congenital Abnormalities
Bone Diseases
Musculoskeletal Abnormalities
Hip Dislocation, Congenital

ClinicalTrials.gov processed this record on May 07, 2009