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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884532
• Other study ID #: 11012
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: September 23, 2016
• Start date: May 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adverse Local Tissue Reaction
• Total Hip Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Incidence of adverse local tissue reaction (ALTR)	To determine trends in the incidence of ALTR over time.	Pre-operatively through 6 years post-operatively	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes