Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
NCT ID: NCT01828801
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
276 participants
OBSERVATIONAL
2013-03-31
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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Pre-Op
Pre-operative patients who will undergo a total hip replacement.
No interventions assigned to this group
1 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 1 year post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
2 year post-op
Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
3 year post-op
Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
4 year post-op
Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
5 year post-op
Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
6 year post-op
Patients that underwent a Pinnacle 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 Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
7 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 7 years post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
8 year post-op
Patients that underwent a Pinnacle Metal-on-Metal (MoM) total hip replacement (THR) and at the time of enrollment, based on their date of surgery, were 8 years post-operative . Alternatively these are patients who have had their Pinnacle Metal-on-Metal hip revised but if they were not revised, would have fallen into this time point.
Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
Interventions
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Pinnacle Metal-on Metal
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle 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 a combination of the following implants in the study hip (unless in pre-op cohort):
1. Pinnacle acetabular shell with or without Gription TM porous coating
2. M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
3. Ultamet metal insert
4. One of the following stems
i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem
4. Subject has high quality films available for review that were taken within 12 months of the 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. Lauenstein Lateral Proximal Femur (Lateral-Femur)
Exclusion Criteria
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
3. The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
4. FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
5. FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip
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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Orange, California, United States
Fort Collins, Colorado, United States
Lone Tree, Colorado, United States
Syracuse, New York, United States
Charlotte, North Carolina, 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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10017
Identifier Type: -
Identifier Source: org_study_id
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