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Completed

NCT Number: NCT01828801

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pinnacle Metal-on Metal

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 11, 2013
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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