Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study

Sponsor

DePuy Orthopaedics (Industry)

Overall Status

Completed

CT.gov ID

NCT01828801

Collaborator

(none)

276

Enrollment

Locations

Duration (Months)

34.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pinnacle Metal-on-Metal Revised Pinnacle Metal-on-Metal Adverse Local Tissue Reaction Metal Ions Total Hip Arthroplasty	Device: Pinnacle Metal-on Metal

Study Design

Study Type:

Observational

Actual Enrollment :

276 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for Pinnacle MoM System Used in Primary Hip Arthroplasty

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pre-Op Pre-operative patients who will undergo a total hip replacement.
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet
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.	Device: Pinnacle Metal-on Metal All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device Other Names: Pinnacle MoM Ultamet

Outcome Measures

Primary Outcome Measures

Change in Chromium serum ion level across time intervals [Pre-operatively through 8 years]
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.
Change in Chromium whole blood ion level across time intervals [Pre-operatively through 8 years]
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.
Change in Cobalt serum ion level across time intervals [Pre-operatively through 8 years]
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.
Change in Cobalt whole blood ion level across time intervals [Pre-operatively through 8 years]
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.

Secondary Outcome Measures

Poolability of data across stem types [Pre-operatively through 8 years post-operatively]
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.
Incidence of adverse local tissue reaction (ALTR) [Pre-operatively through 8 years post-operatively]
To determine trends in the incidence of ALTR over time.
Implant survivorship [Through 8 years post-operatively]
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.
To identify the incidence of ALTR among unrevised subjects [Through 8 years post-operatively]
To identify the incidence of ALTR among unrevised subjects through physical examination and imaging.
Ion levels among revised subjects [Pre-operatively through 8 years post-operatively]
To compare cobalt and chromium ion level (prior to revision) vs. baseline for subjects who are revised.
Harris Hip and HOOS analysis for pain, function and total score [Though 8 years post-operatively]
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.
To determine the association of adverse events with elevated ion levels [Through 8 years post-operatively]
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.
Trending [Through 8 years post-operatively]
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
Patient history and demographics and association with outcomes [Throughout 8 years post-operatively]
Patient demographic and subject history will be evaluated for association with: 1) higher metal ion levels and 2) risk of revision.
Modes and causes of implant failure [Through 8 years post-operatively]
To evaluate modes and causes of implant failure based on an analysis of reasonably available explanted retrieved devices.
Metal ion levels and association with reason for revision [Through 8 years post-operatively]
To compare cobalt and chromium levels across the different reasons for revision.
Comparison of metal ion levels across subjects with vs. without ALTR [Through 8 years post-operatively]
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.
Ion level vs. baseline for ALTR subjects [Through 8 years post-operatively]
To compare cobalt and chromium ion level vs. baseline for subject who are diagnosed with ALTR.
Ion level change from first measurement for ALTR subjects [Through 8 years post-operatively]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	City	State	Country
1	Orange	California	United States
2	Fort Collins	Colorado	United States
3	Lone Tree	Colorado	United States
4	Syracuse	New York	United States
5	Charlotte	North Carolina	United States
6	Durham	North Carolina	United States
7	Cincinnatti	Ohio	United States
8	Austin	Texas	United States