Status:
COMPLETED
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Pinnacle Metal-on-Metal
Revised Pinnacle Metal-on-Metal
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 Pinnacle Acetabular 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 a combination of the following implants in the study hip (unless in pre-op cohort):
- Pinnacle acetabular shell with or without Gription TM porous coating
- M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
- Ultamet metal insert
- One of the following stems
- i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem
- Subject has high quality films available for review that were taken within 12 months of the 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)
- Lauenstein 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 FDA
- The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
- The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
- FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
- FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT01828801
Start Date
March 1 2013
End Date
August 1 2016
Last Update
September 26 2016
Active Locations (8)
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1
Orange, California, United States
2
Fort Collins, Colorado, United States
3
Lone Tree, Colorado, United States
4
Syracuse, New York, United States