Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
NCT ID: NCT00546598
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
106 participants
INTERVENTIONAL
2006-01-01
2014-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Duraloc Option COC Hip
Total hip replacement/arthroplasty
Hip replacement
Interventions
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Total hip replacement/arthroplasty
Hip replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
21 Years
80 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Whalen, BS, DC
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Northside Hospital
Atlanta, Georgia, United States
Memorial Hospital
Springfield, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Fairview Hospital
Cleveland, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Countries
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Other Identifiers
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05024
Identifier Type: -
Identifier Source: org_study_id