Status:
COMPLETED
ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Adverse Local Tissue Reaction
Total Hip Arthroplasty
Eligibility:
All Genders
Brief 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.
Eligibility Criteria
Inclusion
- 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
- One of the following stems
- i. 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01884532
Start Date
May 1 2013
End Date
August 1 2016
Last Update
September 26 2016
Active Locations (7)
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1
Fort Collins, Colorado, United States
2
Glenview, Illinois, United States
3
Rockford, Illinois, United States
4
Las Vegas, Nevada, United States