ASR-XL Metal-on-Metal 522 Post-Market Surveillance Study
Completed
Conditions studied: Adverse Local Tissue Reaction, Total Hip Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT01884532
- Run by
- DePuy Orthopaedics
- People needed
- 146
- Starts
- 2013-05-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2016-09-26
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Study site — Fort Collins, Colorado, United States
- Study site — Glenview, Illinois, United States
- Study site — Rockford, Illinois, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Durham, North Carolina, United States
- Study site — Cincinnatti, Ohio, United States
- Study site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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