Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study

Completed

Conditions studied: Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions, 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 Pinnacle Acetabular MoM system.

Key facts

Study ID

NCT01828801

Run by

DePuy Orthopaedics

People needed

276

Starts

2013-03-01

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 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)

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 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

Where it is running

• Study site — Orange, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Lone Tree, Colorado, United States
• Study site — Syracuse, New York, United States
• Study site — Charlotte, North Carolina, 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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