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

This study has been terminated.
(Sponsor withdrew PMA)
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00546598
First received: October 17, 2007
Last updated: June 25, 2014
Last verified: June 2014
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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 ]
  • 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 ]

Enrollment: 106
Study Start Date: January 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  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
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: NCT00546598

Locations
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
Investigators
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00546598     History of Changes
Other Study ID Numbers: 05024
Study First Received: October 17, 2007
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Hip Dislocation, Congenital
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014