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

Sponsor
DePuy Orthopaedics (Industry)
Overall Status
Terminated
CT.gov ID
NCT00546598
Collaborator
(none)
106
Enrollment
6
Locations
1
Arm
99
Actual Duration (Months)
17.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Total 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 Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
N/A
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
Actual Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Duraloc Option COC Hip

Device: Total hip replacement/arthroplasty
Hip replacement
Other Names:
  • DURALOC® Option Ceramic-on-Ceramic Hip system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survivorship [5 years]

    Secondary Outcome Measures

    1. Study subject SF-12 health survey [1, 2 ,3, 4 and 5 years]

    2. SF-12 Health survey and Subject Outcomes Questionnaire [6, 7, 8, 9 and 10 years]

    3. Hip Function (using Harris Hip Score) [6 weeks, 6 months and 1, 2, 3, 4, and 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northside Hospital Atlanta Georgia United States 30342
    2 Memorial Hospital Springfield Illinois United States 62781
    3 St. John's Hospital Springfield Illinois United States 62781
    4 Fairview Hospital Cleveland Ohio United States 44111
    5 St. Luke's Hospital Maumee Ohio United States 43537
    6 Flower Hospital Sylvania Ohio United States 43560

    Sponsors and Collaborators

    • DePuy Orthopaedics

    Investigators

    • Study Director: Dave Whalen, BS, DC, DePuy Orthopaedics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DePuy Orthopaedics
    ClinicalTrials.gov Identifier:
    NCT00546598
    Other Study ID Numbers:
    • 05024
    First Posted:
    Oct 19, 2007
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by DePuy Orthopaedics
    Total hip replacement, Total hip arthroplasty
    Additional relevant MeSH terms:
    Joint Diseases
    Hip Dislocation
    Developmental Dysplasia of the Hip
    Hip Dislocation, Congenital
    Necrosis

    Study Results

    No Results Posted as of Nov 30, 2021