Non-inflammatory Joint DiseasePhase 4NCT00546598
Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
A Phase 4 study testing Total hip replacement/arthroplasty in people with Non-inflammatory Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Non-inflammatory Joint Disease, Osteoarthritis, Avascular Necrosis
- What is being tested?
- Total hip replacement/arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2006to 1 Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northside Hospital
Atlanta, Georgia, 30342
Fairview Hospital
Cleveland, Ohio, 44111
St. Luke's Hospital
Maumee, Ohio, 43537
Memorial Hospital
Springfield, Illinois, 62781
St. John's Hospital
Springfield, Illinois, 62781
Flower Hospital
Sylvania, Ohio, 43560
About this study
Official title: DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
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:
- a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
- a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
- Conditions
- Non-inflammatory Joint Disease, Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Post-traumatic Arthritis
- Being tested
- Total hip replacement/arthroplasty
- Keywords
- Total hip replacement, Total hip arthroplasty
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement/arthroplastyDevice
Also called DURALOC® Option Ceramic-on-Ceramic Hip system
Hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Duraloc Option COC Hip | Other | Not described Receives: Device: Total hip replacement/arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Measured: 5 years
Secondary outcomes (3)
Study subject SF-12 health survey
Measured: 1, 2 ,3, 4 and 5 years
SF-12 Health survey and Subject Outcomes Questionnaire
Measured: 6, 7, 8, 9 and 10 years
Hip Function (using Harris Hip Score)
Measured: 6 weeks, 6 months and 1, 2, 3, 4, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study start1 Jan 2006
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Why it stopped: Sponsor withdrew PMA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Whalen, BS, DC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546598
- Sponsor's protocol ID
- 05024
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2007
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
- ClinicalTrials.gov ID
- NCT00546598
- Acronym / sponsor ID
- 05024
- Conditions
- Non-inflammatory Joint Disease, Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Post-traumatic Arthritis
- Keywords
- Total hip replacement, Total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew PMA
- Enrolment
- 106 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
- a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duraloc Option COC Hip | Other | Device: Total hip replacement/arthroplasty |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip replacement/arthroplastyAlso: DURALOC® Option Ceramic-on-Ceramic Hip systemHip replacement | Device | Duraloc Option COC Hip |
Primary outcome
Survivorship
Time frame: 5 years
3 secondary outcomes
Study subject SF-12 health survey
Time frame: 1, 2 ,3, 4 and 5 years
SF-12 Health survey and Subject Outcomes Questionnaire
Time frame: 6, 7, 8, 9 and 10 years
Hip Function (using Harris Hip Score)
Time frame: 6 weeks, 6 months and 1, 2, 3, 4, and 5 years
Results and safety
The study was stopped early (reason given: Sponsor withdrew PMA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Whalen, BS, DC study director
DePuy Orthopaedics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total hip replacement/arthroplasty in people with Non-inflammatory Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor withdrew PMA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.