ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study

Cross-Sectional, Multi-Center Evaluation of 6 Year Metal Ion Trends for ASR-XL Total Hip Replacement System

The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the ASR-XL MoM system.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty; Adverse Local Tissue Reaction
• Intervention / Treatment: Device: ASR-XL Metal-on-Metal

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States
  • Illinois
    • Glenview, Illinois, United States
    • Rockford, Illinois, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • North Carolina
    • Durham, North Carolina, United States
  • Ohio
    • Cincinnatti, Ohio, United States
  • Texas
    • Austin, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that have undergone a total hip arthroplasty with the ASR-XL Metal-on-Metal device that are currently 2 to 6 years post-operative.

Description

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 (or had, if previously revised) a combination of the following implants in the study hip:

   1. ASR-XL cup or ASR 300 cup
   2. XL femoral head
   3. ASR-XL tapered sleeve adapter
   4. One of the following stems

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

4. Subject has high quality films available for review that were taken within 12 months of 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. Lauenstien 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 the FDA
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components
3. The femoral component is the ASR hemi or some other hemi device.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2 year post-op; Patients that underwent an ASR-XL 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 ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.	Device: ASR-XL Metal-on-Metal; All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.; Other Names: ASR-XL; ASR-XL MoM
3 year post-op; Patients that underwent an ASR-XL 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 ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.	Device: ASR-XL Metal-on-Metal; All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.; Other Names: ASR-XL; ASR-XL MoM
4 year post-op; Patients that underwent an ASR-XL 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 ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.	Device: ASR-XL Metal-on-Metal; All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.; Other Names: ASR-XL; ASR-XL MoM
5 year post-op; Patients that underwent an ASR-XL 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 ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.	Device: ASR-XL Metal-on-Metal; All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.; Other Names: ASR-XL; ASR-XL MoM
6 year post-op; Patients that underwent an ASR-XL 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 ASR-XL Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.	Device: ASR-XL Metal-on-Metal; All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.; Other Names: ASR-XL; ASR-XL MoM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Chromium serum ion level across time intervals	To compare the chromium serum ion levels in the patient population from pre-operatively through 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.	Pre-operatively through 6 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 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.	Pre-operatively through 6 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 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.	Pre-operatively through 6 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 6 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (2 through 6 years) will be a different cohort of patients. Notes: Pre-operative values are being collected via a separate protocol. There is no 1 year data available for this product due its withdrawal from the market.	Pre-operatively through 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poolability of data across stem types	Within each of the primary analyses, the poolability of the data across stem types will be confirmed with a 2-way ANOVA model in which both time interval and stem type are independent variables. Note: Pre-operative data is being collected via a separate protocol.	Pre-operatively through 6 years post-operatively
Incidence of adverse local tissue reaction (ALTR)	To determine trends in the incidence of ALTR over time.	Pre-operatively through 6 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.	Through 6 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.	Through 6 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. Note: Pre-operative levels are being obtained via a separate protocol.	Pre-operatively through 6 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 subject who are not exhibiting pain or functional symptoms.	Through 6 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.	Through 6 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	Through 6 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	Throughout 6 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.	Through 6 years post-operatively
Metal ion levels and association with reason for revision	To compare cobalt and chromium levels across the different reasons for revision.	Through 6 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 subjects who were diagnosed with an ALTR.	Through 6 years post-operatively
Ion level vs. baseline for ALTR subjects	To compare cobalt and chromium ion level vs. baseline for subjects who are diagnosed with ALTR. Note: Baseline measurements are being captured via a separate protocol.	Through 6 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.	Through 6 years post-operatively

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): September 26, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Serum; Whole Blood; Total Hip Arthroplasty; Metal-on-Metal; Adverse Local Tissue Reaction; Metal Ions; ASR-XL Metal-on-Metal; Revised ASR-XL Metal-on-Metal
• Other Study ID Numbers: 11012 (DAIDS ES Registry Number)