Non-inflammatory Degenerative Joint DiseaseCOC28NCT01657435
28mm Ceramic-on-Ceramic Total Hip Replacement Study
An observational study of Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 13 sites in 2 countries.
Trial summary
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis
- What is being tested?
- Ceramax Acetabular System
- Type of treatment
- Medical device
- How many people
- 185 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 May 2012to 24 Sep 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and females who are appropriate candidates for primary hip replacement o any age, with non-inflammatory degenerative joint disease or: males and females that had a primary hip replacement with CERAMAX as part of the 28 mm IDE study.
Who may be able to join
- Subjects who were previously enrolled in the COC28 IDE study, or
- Newly recruited individuals who are qualified based on the approved labeling of the device, and;
- Individuals who are willing and able to provide informed patient consent for participation in the study;
- Individuals who are willing and able to return for follow-up as specified by the study protocol; and
- Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol
Who cannot join
- In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Anderson Orthopaedic Research Institute
Alexandria, Virginia
New England Baptist Hospital
Boston, Massachusetts, 02120
Tufts - New England Medical Center
Boston, Massachusetts
Cardinal Orthopaedic Institute
Columbus, Ohio
Colorado Joint Replacement
Denver, Colorado, 80210
Duke University
Durham, North Carolina
Study site
Fort Collins, Colorado
Florida University
Gainesville, Florida
UPenn
Philadelphia, Pennsylvania, 19104
Joint Surgeons of Sacremento
Sacramento, California
FOI Florida Orthopaedic Institute
Tampa, Florida
OrthoCarolina
Winston-Salem, North Carolina
Canada1 site
McGill University - Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.
In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
Read the detailed description
This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:
- a clinical follow-up phase and
- a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis
- Being tested
- Ceramax Acetabular System
- Keywords
- Total hip replacement, Total hip arthroplasty, Hip joint replacement, Hip prosthesis replacement
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramax Acetabular SystemDevice
Also called Ceramic-on-ceramic 28 mm Acetabular Cup
28mm Ceramic-on-ceramic Acetabular Cup System
| Study group | Role | What they receive |
|---|---|---|
| Ceramax COC 28mm Acetabular Cup | The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper. Receives: Device: Ceramax Acetabular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.
Measured: 10 years
Secondary outcomes (3)
Harris Hip Score
At five years, the Harris Hip Score must be > 80 points or higher and the Harris Hip pain assessment must be mild or no pain.
Measured: 5 years
Radiographic
At 5 years, secondary radiographic outcome measures will include:
- No radiolucencies >2mm in any zone in any post-operative interval;
- No acetabular cup migration >4mm;
- No change in cup inclination angle >4 degrees when compared to immediate post-operative angle; and
- No osteolysis.
Measured: 5 years
Survivorship
At 5 years, the secondary outcome measure will include no components removed for any reason.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start1 May 2012
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Why it stopped: Adequate data to satisfy PAS as agreed to with FDA 02OCT2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tammy L ODell, BS CCRC CCRA, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657435
- Sponsor's protocol ID
- 09001
- Acronym
- COC28
- Status last verified
- Nov 2019
- First submitted
- 2 Aug 2012
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
- ClinicalTrials.gov ID
- NCT01657435
- Acronym / sponsor ID
- COC28 / 09001
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis
- Keywords
- Total hip replacement, Total hip arthroplasty, Hip joint replacement, Hip prosthesis replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Adequate data to satisfy PAS as agreed to with FDA 02OCT2019
- Enrolment
- 185 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2012 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 6 Aug 2012 (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 intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.
In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
Detailed description
This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:
- a clinical follow-up phase and
- a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceramax COC 28mm Acetabular Cup | – | Device: Ceramax Acetabular SystemThe 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and females who are appropriate candidates for primary hip replacement o any age, with non-inflammatory degenerative joint disease or: males and females that had a primary hip replacement with CERAMAX as part of the 28 mm IDE study.
Key inclusion criteria (5 listed)
- Subjects who were previously enrolled in the COC28 IDE study, or
- Newly recruited individuals who are qualified based on the approved labeling of the device, and;
- Individuals who are willing and able to provide informed patient consent for participation in the study;
- Individuals who are willing and able to return for follow-up as specified by the study protocol; and
- Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol
Key exclusion criteria (1 listed)
- In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.
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 |
|---|---|---|
| Ceramax Acetabular SystemAlso: Ceramic-on-ceramic 28 mm Acetabular Cup28mm Ceramic-on-ceramic Acetabular Cup System | Device | Ceramax COC 28mm Acetabular Cup |
Primary outcome
Survivorship
Time frame: 10 years
The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.
3 secondary outcomes
Harris Hip Score
Time frame: 5 years
Radiographic
Time frame: 5 years
Survivorship
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Adequate data to satisfy PAS as agreed to with FDA 02OCT2019). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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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.
Tammy L ODell, BS CCRC CCRA study director
DePuy Orthopaedics
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 13 sites in 2 countries.
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 5 inclusion and 1 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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.
Are results available for this study?
The study was stopped early (reason given: Adequate data to satisfy PAS as agreed to with FDA 02OCT2019). 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: 10 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 19 Nov 2019.