An observational study in Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal and Adverse Local Tissue Reaction, sponsored by DePuy Orthopaedics. Completed at 8 sites in United States. Per ClinicalTrials.gov, last updated 2016-09-26.
Sponsored by DePuy Orthopaedics · Observational
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.
DePuy Orthopaedics is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients that have undergone a total hip arthroplasty with the Pinnacle Metal-on-Metal device within the past 8 years.
Subject has a combination of the following implants in the study hip (unless in pre-op cohort):
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:
Exclusion Criteria:
Pre-operative patients who will undergo a total hip replacement.
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
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.
Device: Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Also known as: Pinnacle MoM, Ultamet
Change in Chromium serum ion level across time intervals
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.
Time frame: Pre-operatively through 8 years
Change in Chromium whole blood ion level across time intervals
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.
Time frame: Pre-operatively through 8 years
Change in Cobalt serum ion level across time intervals
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.
Time frame: Pre-operatively through 8 years
Change in Cobalt whole blood ion level across time intervals
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.
Time frame: Pre-operatively through 8 years
Poolability of data across stem types
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.
Time frame: Pre-operatively through 8 years post-operatively
Incidence of adverse local tissue reaction (ALTR)
To determine trends in the incidence of ALTR over time.
Time frame: Pre-operatively through 8 years post-operatively
Implant survivorship
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.
Time frame: Through 8 years post-operatively
To identify the incidence of ALTR among unrevised subjects
To identify the incidence of ALTR among unrevised subjects through physical examination and imaging.
Time frame: Through 8 years post-operatively
Ion levels among revised subjects
To compare cobalt and chromium ion level (prior to revision) vs. baseline for subjects who are revised.
Time frame: Pre-operatively through 8 years post-operatively
Harris Hip and HOOS analysis for pain, function and total score
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.
Time frame: Though 8 years post-operatively
To determine the association of adverse events with elevated ion levels
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.
Time frame: Through 8 years post-operatively
Trending
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
Time frame: Through 8 years post-operatively
Patient history and demographics and association with outcomes
Patient demographic and subject history will be evaluated for association with: 1) higher metal ion levels and 2) risk of revision.
Time frame: Throughout 8 years post-operatively
Modes and causes of implant failure
To evaluate modes and causes of implant failure based on an analysis of reasonably available explanted retrieved devices.
Time frame: Through 8 years post-operatively
Metal ion levels and association with reason for revision
To compare cobalt and chromium levels across the different reasons for revision.
Time frame: Through 8 years post-operatively
Comparison of metal ion levels across subjects with vs. without ALTR
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.
Time frame: Through 8 years post-operatively
Ion level vs. baseline for ALTR subjects
To compare cobalt and chromium ion level vs. baseline for subject who are diagnosed with ALTR.
Time frame: Through 8 years post-operatively
Ion level change from first measurement for ALTR subjects
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.
Time frame: Through 8 years post-operatively
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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DePuy Orthopaedics