- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096198
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement (COC36mmPAS)
36mm CERAMAX® Ceramic Hip System PMA PAS: Long-Term Follow-up of Previously Enrolled Investigational Device Exemption (IDE) Study Subjects
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States
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Colorado
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Denver, Colorado, United States
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North Carolina
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Winston-Salem, North Carolina, United States
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Ohio
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Columbus, Ohio, United States, 43213
- Orthopedic One
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Virginia
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Alexandria, Virginia, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Device survivorship at 10-years post-operatively
Time Frame: 10-years post-operatively
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Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10-years post-operatively.
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10-years post-operatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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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)
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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)
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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. |
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)
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Radiographic
Time Frame: At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
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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:
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. |
At first visit (5-7 years), at Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015 days)
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Adverse Events
Time Frame: First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
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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.
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First visit at 5-7 years (1825- 2919 days); Minimum 8-years (2920-3649 days); Minimum 10-years (3650-4015days)
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Device survivorship
Time Frame: 5-years, 6-years, 7-years, 8-years, and 9-years
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Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at years 5 through 9 post-operatively
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5-years, 6-years, 7-years, 8-years, and 9-years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11013 (DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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