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TerminatedNCT00546598Updated Nov 30, 2021

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

A Phase 4 interventional study of Total hip replacement/arthroplasty in Non-inflammatory Joint Disease, Osteoarthritis and Avascular Necrosis, sponsored by DePuy Orthopaedics. Terminated at 6 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-30.

Sponsored by DePuy Orthopaedics · Phase 4, Interventional, and Treatment

Why this study was terminated
Sponsor withdrew PMA

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2006, registered Oct 2007).
Phase
Phase 4
Study type
Interventional
Enrollment
106
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Non-inflammatory Joint Disease
  • Osteoarthritis
  • Avascular Necrosis
  • Congenital Hip Dysplasia
  • Post-traumatic Arthritis

Keywords

  • Total hip replacement, Total hip arthroplasty
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 106 is above the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

DePuy Orthopaedics is the lead sponsor of 42 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
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

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.)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Other
    Duraloc Option COC Hip

    Device: Total hip replacement/arthroplasty

Interventions

  • DeviceTotal hip replacement/arthroplasty

    Hip replacement

    Also known as: DURALOC® Option Ceramic-on-Ceramic Hip system

06

What researchers measure

Primary outcomes

  1. Survivorship

    Time frame: 5 years

Secondary outcomes

  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

07

Study locations

6 sites
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Memorial Hospital
    Springfield, Illinois 62781, United States
  • St. John's Hospital
    Springfield, Illinois 62781, United States
  • Fairview Hospital
    Cleveland, Ohio 44111, United States
  • St. Luke's Hospital
    Maumee, Ohio 43537, United States
  • Flower Hospital
    Sylvania, Ohio 43560, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00546598
Lead sponsor
DePuy Orthopaedics
Responsible party
Sponsor
First posted
Oct 19, 2007
Start date
Jan 1, 2006
Primary completion
Apr 1, 2014
Completion
Apr 1, 2014
Last update
Nov 30, 2021

Study contacts

Dave Whalen, BS, DC
study director · DePuy Orthopaedics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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