- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828801
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
September 23, 2016 updated by: DePuy Orthopaedics
Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for Pinnacle MoM System Used in Primary Hip Arthroplasty
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
276
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Orange, California, United States
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Colorado
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Fort Collins, Colorado, United States
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Lone Tree, Colorado, United States
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New York
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Syracuse, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Ohio
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Cincinnatti, Ohio, United States
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Texas
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Austin, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients that have undergone a total hip arthroplasty with the Pinnacle Metal-on-Metal device within the past 8 years.
Description
Inclusion Criteria:
- Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation
- Is willing and able to return for all protocol defined clinic visits
Subject has a combination of the following implants in the study hip (unless in pre-op cohort):
- Pinnacle acetabular shell with or without Gription TM porous coating
- M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
- Ultamet metal insert
- One of the following stems
i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem
Subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views:
- Standing AP-Pelvis
- Standing AP-Proximal Femur (if this view is not available but the AP-Pelvis shows the entire implant and greater trochanter, that is also acceptable)
- Lauenstein Lateral Proximal Femur (Lateral-Femur)
Exclusion Criteria:
- The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, the medical office staff and/or representatives from FDA
- The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
- The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
- FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
- FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Pre-Op
Pre-operative patients who will undergo a total hip replacement.
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1 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 1 year post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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2 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 2 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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3 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 3 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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4 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 4 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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5 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 5 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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6 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 6 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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7 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 7 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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8 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 8 years post-operative .
Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
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All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Chromium serum ion level across time intervals
Time Frame: Pre-operatively through 8 years
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To compare the chromium serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA.
This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
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Pre-operatively through 8 years
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Change in Chromium whole blood ion level across time intervals
Time Frame: Pre-operatively through 8 years
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To compare the chromium whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA.
This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
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Pre-operatively through 8 years
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Change in Cobalt serum ion level across time intervals
Time Frame: Pre-operatively through 8 years
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To compare the cobalt serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA.
This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
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Pre-operatively through 8 years
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Change in Cobalt whole blood ion level across time intervals
Time Frame: Pre-operatively through 8 years
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To compare the cobalt whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA.
This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
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Pre-operatively through 8 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Poolability of data across stem types
Time Frame: Pre-operatively through 8 years post-operatively
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Within each of the primary analyses, the poolability of data across stem types will be confirmed with a 2-way ANOVA model in which both time interval and stem type are independent variables.
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Pre-operatively through 8 years post-operatively
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Incidence of adverse local tissue reaction (ALTR)
Time Frame: Pre-operatively through 8 years post-operatively
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To determine trends in the incidence of ALTR over time.
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Pre-operatively through 8 years post-operatively
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Implant survivorship
Time Frame: Through 8 years post-operatively
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To determine implant survivorship, where an implant is considered to be surviving when none of the total hip replacement (THR) system components have been removed or replaced, so that the original system with metal-on-metal (MoM) articulating surfaces remains intact.
Implant survivorship will be analyzed in two ways: 1) for all revisions (for any reason) and 2) for revisions due to ALTR.
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Through 8 years post-operatively
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To identify the incidence of ALTR among unrevised subjects
Time Frame: Through 8 years post-operatively
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To identify the incidence of ALTR among unrevised subjects through physical examination and imaging.
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Through 8 years post-operatively
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Ion levels among revised subjects
Time Frame: Pre-operatively through 8 years post-operatively
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To compare cobalt and chromium ion level (prior to revision) vs. baseline for subjects who are revised.
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Pre-operatively through 8 years post-operatively
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Harris Hip and HOOS analysis for pain, function and total score
Time Frame: Though 8 years post-operatively
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To identify the incidence of pain or functional symptoms among unrevised subjects with a Harris Hip and HOOS evaluation.
To compare cobalt and chromium ion levels for unrevised subject who are exhibiting pain or functional symptoms vs. unrevised subjects who are not exhibiting pain or functional symptoms.
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Though 8 years post-operatively
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To determine the association of adverse events with elevated ion levels
Time Frame: Through 8 years post-operatively
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To investigate the association of adverse events with elevated cobalt and chromium ion levels.
For each respective adverse event, to compare cobalt and chromium ion levels for subjects who have vs. subjects who have not exhibited the adverse event.
For each respective adverse event category, to present summary statistics of cobalt and chromium ion levels for subjects who have vs. subjects who have not exhibited the adverse event, stratified by post-op time cohort.
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Through 8 years post-operatively
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Trending
Time Frame: Through 8 years post-operatively
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Trends (over time since initial implant) will be evaluated for: 1) revisions (survivorship), 2) adverse events, 3) pain or functional symptoms (via Harris Hip and HOOS evaluations), 4) incidence of ALTR in unrevised subjects
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Through 8 years post-operatively
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Patient history and demographics and association with outcomes
Time Frame: Throughout 8 years post-operatively
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Patient demographic and subject history will be evaluated for association with: 1) higher metal ion levels and 2) risk of revision.
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Throughout 8 years post-operatively
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Modes and causes of implant failure
Time Frame: Through 8 years post-operatively
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To evaluate modes and causes of implant failure based on an analysis of reasonably available explanted retrieved devices.
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Through 8 years post-operatively
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Metal ion levels and association with reason for revision
Time Frame: Through 8 years post-operatively
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To compare cobalt and chromium levels across the different reasons for revision.
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Through 8 years post-operatively
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Comparison of metal ion levels across subjects with vs. without ALTR
Time Frame: Through 8 years post-operatively
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Cobalt and Chromium ion levels will be compared for unrevised subjects who were not diagnosed with an ALTR vs. unrevised subject who were diagnosed with an ALTR.
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Through 8 years post-operatively
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Ion level vs. baseline for ALTR subjects
Time Frame: Through 8 years post-operatively
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To compare cobalt and chromium ion level vs. baseline for subject who are diagnosed with ALTR.
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Through 8 years post-operatively
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Ion level change from first measurement for ALTR subjects
Time Frame: Through 8 years post-operatively
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Cobalt and chromium ion levels will be compared from first measurement to the time of revision (prior to revision) or the time of last follow-up visit in the study, whichever comes first, for subjects who are diagnosed with an ALTR.
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Through 8 years post-operatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
April 2, 2013
First Submitted That Met QC Criteria
April 8, 2013
First Posted (ESTIMATE)
April 11, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 26, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10017 (Other Identifier: CTEP)
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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