Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546598
Recruitment Status : Terminated (Sponsor withdrew PMA)
First Posted : October 19, 2007
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
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 or disease Intervention/treatment Phase
Non-inflammatory Joint Disease Osteoarthritis Avascular Necrosis Congenital Hip Dysplasia Post-traumatic Arthritis Device: Total hip replacement/arthroplasty Device: Hip replacement/arthroplasty Phase 4

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:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
Study Start Date : January 2006
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
Duraloc Option COC Hip Device: Total hip replacement/arthroplasty
Hip replacement
Other Name: DURALOC® Option Ceramic-on-Ceramic Hip system
Device: Hip replacement/arthroplasty
Hip replacement
Other Name: DURALOC® Option Ceramic-on-Ceramic Hip system

Primary Outcome Measures :
  1. Survivorship [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Study subject SF-12 health survey [ Time Frame: 1, 2 ,3, 4 and 5 years ]
  2. SF-12 Health survey and Subject Outcomes Questionnaire [ Time Frame: 6, 7, 8, 9 and 10 years ]
  3. Hip Function (using Harris Hip Score) [ Time Frame: 6 weeks, 6 months and 1, 2, 3, 4, and 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546598

United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Memorial Hospital
Springfield, Illinois, United States, 62781
St. John's Hospital
Springfield, Illinois, United States, 62781
United States, Ohio
Fairview Hospital
Cleveland, Ohio, United States, 44111
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Flower Hospital
Sylvania, Ohio, United States, 43560
Sponsors and Collaborators
DePuy Orthopaedics
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics Identifier: NCT00546598     History of Changes
Other Study ID Numbers: 05024
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by DePuy Orthopaedics:
Total hip replacement, Total hip arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Hip Dislocation
Hip Dislocation, Congenital
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Bone Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities