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

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ClinicalTrials.gov Identifier: NCT01828801
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

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
Pinnacle Metal-on-Metal Revised Pinnacle Metal-on-Metal Adverse Local Tissue Reaction Metal Ions Total Hip Arthroplasty Device: Pinnacle Metal-on Metal

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 : March 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : August 2016

Group/Cohort 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




Primary Outcome Measures :
  1. Change in Chromium serum ion level across time intervals [ Time Frame: 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.

  2. Change in Chromium whole blood ion level across time intervals [ Time Frame: 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.

  3. Change in Cobalt serum ion level across time intervals [ Time Frame: 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.

  4. Change in Cobalt whole blood ion level across time intervals [ Time Frame: 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 :
  1. Poolability of data across stem types [ Time Frame: 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.

  2. Incidence of adverse local tissue reaction (ALTR) [ Time Frame: Pre-operatively through 8 years post-operatively ]
    To determine trends in the incidence of ALTR over time.

  3. Implant survivorship [ Time Frame: 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.

  4. To identify the incidence of ALTR among unrevised subjects [ Time Frame: Through 8 years post-operatively ]
    To identify the incidence of ALTR among unrevised subjects through physical examination and imaging.

  5. Ion levels among revised subjects [ Time Frame: Pre-operatively through 8 years post-operatively ]
    To compare cobalt and chromium ion level (prior to revision) vs. baseline for subjects who are revised.

  6. Harris Hip and HOOS analysis for pain, function and total score [ Time Frame: 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.

  7. To determine the association of adverse events with elevated ion levels [ Time Frame: 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.

  8. Trending [ Time Frame: 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

  9. Patient history and demographics and association with outcomes [ Time Frame: 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.

  10. Modes and causes of implant failure [ Time Frame: Through 8 years post-operatively ]
    To evaluate modes and causes of implant failure based on an analysis of reasonably available explanted retrieved devices.

  11. Metal ion levels and association with reason for revision [ Time Frame: Through 8 years post-operatively ]
    To compare cobalt and chromium levels across the different reasons for revision.

  12. Comparison of metal ion levels across subjects with vs. without ALTR [ Time Frame: 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.

  13. Ion level vs. baseline for ALTR subjects [ Time Frame: Through 8 years post-operatively ]
    To compare cobalt and chromium ion level vs. baseline for subject who are diagnosed with ALTR.

  14. Ion level change from first measurement for ALTR subjects [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole blood and serum samples are retained.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation
  2. Is willing and able to return for all protocol defined clinic visits
  3. Subject has a combination of the following implants in the study hip (unless in pre-op cohort):

    1. Pinnacle acetabular shell with or without Gription TM porous coating
    2. M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
    3. Ultamet metal insert
    4. One of the following stems

    i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem

  4. Subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views:

    1. Standing AP-Pelvis
    2. 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)
    3. Lauenstein Lateral Proximal Femur (Lateral-Femur)

Exclusion Criteria:

  1. 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
  2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
  3. The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
  4. FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
  5. FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828801


Locations
United States, California
Orange, California, United States
United States, Colorado
Fort Collins, Colorado, United States
Lone Tree, Colorado, United States
United States, New York
Syracuse, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Durham, North Carolina, United States
United States, Ohio
Cincinnatti, Ohio, United States
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Mary F Panozzo, BS DePuy Synthes Joint Reconstruction

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01828801     History of Changes
Other Study ID Numbers: 10017
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: May 2016

Keywords provided by DePuy Orthopaedics:
Adverse Local Tissue Reaction
Metal Ions
Serum
Whole Blood
Metal-on-Metal
Total Hip Arthroplasty