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

DePuy Orthopaedics276 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

276

Conditions

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

Interventions

Pinnacle Metal-on MetalDEVICE

All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Orange, California, United States

Unnamed facility

Fort Collins, Colorado, United States

Unnamed facility

Lone Tree, Colorado, United States

Unnamed facility

Syracuse, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Unnamed facility

Charlotte, North Carolina, United States

Unnamed facility

Durham, North Carolina, United States

Unnamed facility

Cincinnatti, Ohio, United States

Unnamed facility

Austin, Texas, United States

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