Non-inflammatory Degenerative Joint DiseaseCOC36mmPASNCT02096198
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
An observational study of Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 5 sites in United States.
Trial summary
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis
- How many people
- 81 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2014to 20 Aug 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects from the original IDE study who have already been implanted with a Ceramax 36mm ceramic-on-ceramic system and who have given their consent for this study
Who may be able to join
- Subjects who were previously enrolled in the COC 36 IDE study;
- 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 Subject Hip Outcomes questionnaire as specified by the study protocol.
Who cannot join
- In the opinion of the Investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations.
- Any component of the primary total hip was previously revised.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Alexandria, Virginia
Orthopedic One
Columbus, Ohio, 43213
Study site
Denver, Colorado
Study site
Sacramento, California
Study site
Winston-Salem, North Carolina
About this study
Official title: 36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the COC total hip replacement system)
Read the detailed description
Up to five (5) sites will participate. These sites participated in the IDE study and will continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Other CERAMAX COC 36mm Acetabular Cup | The CERAMAX COC 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device survivorship at 10-years post-operatively
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.
Measured: 10-years post-operatively
Secondary outcomes (5)
Harris Hip scores
The Harris Hip score consists of five sub-scales: Pain, Function, Activities Deformity and Range of motion. The instrument is designed for completion by a clinician.
Measured: Harris Hip score means and Harris Hip sub-score means will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Subject Hip Outcomes
Subject Hip Outcomes is a standardized instrument for use as a measure of health outcome that is designed for completion by the study subject. This hips outcomes self-assessment includes five (5) questions about subject satisfaction and hip function. The 5 questions relate to study subject function, pain, need for pain meds, satisfaction and their status (i.e., better, same or worse).
The percent of subjects who answer 'Yes' or 'Better' on each respective question will be reported.
Measured: Subject Hip Outcomes will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Radiographic
At 5 to 7 years, at Minimum 8-years and at minimum 10-years, secondary radiographic outcome measures will include high quality antero-posterior and lateral radiographs of the operative hip, which will be obtained during the same postoperative follow-up intervals as for the clinical evaluations. At the first "enrollment" visit (5-7 years), an additional Cross-Table Lateral films will be collected to permit assessment of cup positioning.
Radiographic views will include:
- AP Pelvis
- AP femur
- Lauenstein Lateral
- Cross-Table Lateral (only at the first visit at 5-7 years)
As a single composite radiographic outcome, the percent of subjects with radiolucencies greater than 2 mm in any zone, acetabular cup migration greater than 4 mm, change in cup inclination greater than 4 degrees or osteolysis at the time of last radiographic assessment will be reported.
Measured: At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
Adverse Events
Subjects who consent to participate in this trial have already had their index surgery for implantation of the study hip; however, potential adverse events may still occur and will be captured at each follow-up visit.
Measured: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Device survivorship
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at years 5 through 9 post-operatively
Measured: 5-years, 6-years, 7-years, 8-years, and 9-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start1 Jan 2014
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096198
- Sponsor's protocol ID
- 11013
- Acronym
- COC36mmPAS
- Status last verified
- Jan 2019
- First submitted
- 21 Mar 2014
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
- ClinicalTrials.gov ID
- NCT02096198
- Acronym / sponsor ID
- COC36mmPAS / 11013
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Keywords
- Total Hip Replacement, Total Hip Arthroplasty, Hip Joint Replacement, Hip Prosthesis Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 26 Mar 2014 (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 (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System from a cohort of study subjects that were previously enrolled in the IDE study. (COC = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the COC total hip replacement system)
Detailed description
Up to five (5) sites will participate. These sites participated in the IDE study and will continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other CERAMAX COC 36mm Acetabular Cup | – | –The CERAMAX COC 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from the original IDE study who have already been implanted with a Ceramax 36mm ceramic-on-ceramic system and who have given their consent for this study
Key inclusion criteria (4 listed)
- Subjects who were previously enrolled in the COC 36 IDE study;
- 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 Subject Hip Outcomes questionnaire as specified by the study protocol.
Key exclusion criteria (2 listed)
- In the opinion of the Investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations.
- Any component of the primary total hip was previously revised.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device survivorship at 10-years post-operatively
Time frame: 10-years post-operatively
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.
5 secondary outcomes
Harris Hip scores
Time frame: Harris Hip score means and Harris Hip sub-score means will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Subject Hip Outcomes
Time frame: Subject Hip Outcomes will be estimated at the First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Radiographic
Time frame: At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
Adverse Events
Time frame: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
Device survivorship
Time frame: 5-years, 6-years, 7-years, 8-years, and 9-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: 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 5 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device survivorship at 10-years post-operatively (time frame: 10-years post-operatively). 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 29 Jan 2019.