ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
NCT ID: NCT01884532
Last Updated: 2016-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
146 participants
OBSERVATIONAL
2013-05-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Mary F Panozzo, BS
Role: STUDY_DIRECTOR
DePuy Synthes Joint Reconstruction
Locations
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Fort Collins, Colorado, United States
Glenview, Illinois, United States
Rockford, Illinois, United States
Las Vegas, Nevada, United States
Durham, North Carolina, United States
Cincinnatti, Ohio, United States
Austin, Texas, United States
Countries
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Other Identifiers
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11012
Identifier Type: -
Identifier Source: org_study_id
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