Adverse Local Tissue ReactionNCT01884532
ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
An observational study of Adverse Local Tissue Reaction and Total Hip Arthroplasty, run by DePuy Orthopaedics at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Local Tissue Reaction, Total Hip Arthroplasty
- What is being tested?
- ASR-XL Metal-on-Metal
- Type of treatment
- Medical device
- How many people
- 146 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2013to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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 (or had, if previously revised) a combination of the following implants in the study hip:
- ASR-XL cup or ASR 300 cup
- XL femoral head
- ASR-XL tapered sleeve adapter
Show all 12Show fewer
- One of the following stems
- S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem AMT
- Subject has high quality films available for review that were taken within 12 months of 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)
- Lauenstien Lateral Proximal Femur (Lateral-femur).
Who cannot join
- 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
- The implanted hip components in the study hip (exclusive of cement), are not all DePuy components
- The femoral component is the ASR hemi or some other hemi device.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Austin, Texas
Study site
Cincinnatti, Ohio
Study site
Durham, North Carolina
Study site
Fort Collins, Colorado
Study site
Glenview, Illinois
Study site
Las Vegas, Nevada
Study site
Rockford, Illinois
About this study
Official title: 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.
- Being tested
- ASR-XL Metal-on-Metal
- Keywords
- Adverse Local Tissue Reaction, Metal Ions, Serum, Whole Blood, Metal-on-Metal, Total Hip Arthroplasty, ASR-XL Metal-on-Metal, Revised ASR-XL Metal-on-Metal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASR-XL Metal-on-MetalDevice
Also called ASR-XL, ASR-XL MoM
All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ASR-XL Metal-on-Metal | |
| 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. Receives: Device: ASR-XL Metal-on-Metal | |
| 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. Receives: Device: ASR-XL Metal-on-Metal | |
| 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. Receives: Device: ASR-XL Metal-on-Metal | |
| 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. Receives: Device: ASR-XL Metal-on-Metal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operatively through 6 years
Secondary outcomes (14)
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.
Measured: Pre-operatively through 6 years post-operatively
Incidence of adverse local tissue reaction (ALTR)
To determine trends in the incidence of ALTR over time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 6 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Local Tissue ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary F Panozzo, BS, Study director, DePuy Synthes Joint Reconstruction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884532
- Sponsor's protocol ID
- 11012
- Status last verified
- May 2016
- First submitted
- 19 Jun 2013
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional, Multi-Center Evaluation of 6 Year Metal Ion Trends for ASR-XL Total Hip Replacement System
- ClinicalTrials.gov ID
- NCT01884532
- Acronym / sponsor ID
- 11012
- Keywords
- Adverse Local Tissue Reaction, Metal Ions, Serum, Whole Blood, Metal-on-Metal, Total Hip Arthroplasty, ASR-XL Metal-on-Metal, Revised ASR-XL Metal-on-Metal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 year post-op | – | Device: ASR-XL Metal-on-MetalPatients 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. |
| 3 year post-op | – | Device: ASR-XL Metal-on-MetalPatients 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. |
| 4 year post-op | – | Device: ASR-XL Metal-on-MetalPatients 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. |
| 5 year post-op | – | Device: ASR-XL Metal-on-MetalPatients 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. |
| 6 year post-op | – | Device: ASR-XL Metal-on-MetalPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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 (or had, if previously revised) a combination of the following implants in the study hip:
- Subject has high quality films available for review that were taken within 12 months of primary surgery of the following views:
Key exclusion criteria (3 listed)
- 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
- The implanted hip components in the study hip (exclusive of cement), are not all DePuy components
- The femoral component is the ASR hemi or some other hemi device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASR-XL Metal-on-MetalAlso: ASR-XL, ASR-XL MoMAll patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device. | Device | 2 year post-op, 3 year post-op, 4 year post-op, 5 year post-op, 6 year post-op |
Primary outcome
Change in Chromium serum ion level across time intervals
Time frame: Pre-operatively through 6 years
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.
Change in Chromium whole blood ion level across time intervals
Time frame: Pre-operatively through 6 years
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.
Change in Cobalt serum ion level across time intervals
Time frame: Pre-operatively through 6 years
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.
Change in Cobalt whole blood ion level across time intervals
Time frame: Pre-operatively through 6 years
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.
14 secondary outcomes
Poolability of data across stem types
Time frame: Pre-operatively through 6 years post-operatively
Incidence of adverse local tissue reaction (ALTR)
Time frame: Pre-operatively through 6 years post-operatively
Implant survivorship
Time frame: Through 6 years post-operatively
To identify the incidence of ALTR among unrevised subjects
Time frame: Through 6 years post-operatively
Ion levels among revised subjects
Time frame: Pre-operatively through 6 years post-operatively
Harris Hip and HOOS analysis for pain, function and total score
Time frame: Through 6 years post-operatively
To determine the association of adverse events with elevated ion levels
Time frame: Through 6 years post-operatively
Trending
Time frame: Through 6 years post-operatively
Patient history and demographics and association with outcomes
Time frame: Throughout 6 years post-operatively
Modes and causes of implant failure
Time frame: Through 6 years post-operatively
Metal ion levels and association with reason for revision
Time frame: Through 6 years post-operatively
Comparison of metal ion levels across subjects with vs. without ALTR
Time frame: Through 6 years post-operatively
Ion level vs. baseline for ALTR subjects
Time frame: Through 6 years post-operatively
Ion level change from first measurement for ALTR subjects
Time frame: Through 6 years post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary F Panozzo, BS study director
DePuy Synthes Joint Reconstruction
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Local Tissue Reaction and Total Hip Arthroplasty, run by DePuy Orthopaedics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chromium serum ion level across time intervals (time frame: Pre-operatively through 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.