Pinnacle Metal-on-MetalNCT01828801

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

An observational study of Pinnacle Metal-on-Metal and Revised Pinnacle Metal-on-Metal, run by DePuy Orthopaedics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction
What is being tested?: Pinnacle Metal-on Metal
Type of treatment: Medical device
How many people: 276 participants
Where: 8 sitesUnited States
Study dates: Mar 2013to Aug 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients that have undergone a total hip arthroplasty with the Pinnacle Metal-on-Metal device within the past 8 years.

Who may be able to join

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

Show all 12Show fewer

One of the following stems
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)

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Austin, Texas
Study site
Charlotte, North Carolina
Study site
Cincinnatti, Ohio
Study site
Durham, North Carolina
Study site
Fort Collins, Colorado
Study site
Lone Tree, Colorado
Study site
Orange, California
Study site
Syracuse, New York

Other trials in United States

About this study

Official title: Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for Pinnacle MoM System Used in Primary Hip Arthroplasty

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.

Conditions: Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions, Total Hip Arthroplasty
Being tested: Pinnacle Metal-on Metal
Keywords: Adverse Local Tissue Reaction, Metal Ions, Serum, Whole Blood, Metal-on-Metal, Total Hip Arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pinnacle Metal-on MetalDevice
Also called Pinnacle MoM, Ultamet
All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device

Study groups in NCT01828801
Study group	Role	What they receive
Pre-Op		Pre-operative patients who will undergo a total hip replacement.
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal
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. Receives: Device: Pinnacle Metal-on Metal

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Chromium serum ion level across time intervals
To compare the chromium serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Measured: Pre-operatively through 8 years
Change in Chromium whole blood ion level across time intervals
To compare the chromium whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Measured: Pre-operatively through 8 years
Change in Cobalt serum ion level across time intervals
To compare the cobalt serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Measured: Pre-operatively through 8 years
Change in Cobalt whole blood ion level across time intervals
To compare the cobalt whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Measured: Pre-operatively through 8 years

Secondary outcomes (14)

Poolability of data across stem types
Within each of the primary analyses, the poolability of data across stem types will be confirmed with a 2-way ANOVA model in which both time interval and stem type are independent variables.
Measured: Pre-operatively through 8 years post-operatively
Incidence of adverse local tissue reaction (ALTR)
To determine trends in the incidence of ALTR over time.
Measured: Pre-operatively through 8 years post-operatively
Implant survivorship
To determine implant survivorship, where an implant is considered to be surviving when none of the total hip replacement (THR) system components have been removed or replaced, so that the original system with metal-on-metal (MoM) articulating surfaces remains intact. Implant survivorship will be analyzed in two ways: 1) for all revisions (for any reason) and 2) for revisions due to ALTR.
Measured: Through 8 years post-operatively
To identify the incidence of ALTR among unrevised subjects
To identify the incidence of ALTR among unrevised subjects through physical examination and imaging.
Measured: Through 8 years post-operatively
Ion levels among revised subjects
To compare cobalt and chromium ion level (prior to revision) vs. baseline for subjects who are revised.
Measured: Pre-operatively through 8 years post-operatively
Harris Hip and HOOS analysis for pain, function and total score
To identify the incidence of pain or functional symptoms among unrevised subjects with a Harris Hip and HOOS evaluation. To compare cobalt and chromium ion levels for unrevised subject who are exhibiting pain or functional symptoms vs. unrevised subjects who are not exhibiting pain or functional symptoms.
Measured: Though 8 years post-operatively
To determine the association of adverse events with elevated ion levels
To investigate the association of adverse events with elevated cobalt and chromium ion levels. For each respective adverse event, to compare cobalt and chromium ion levels for subjects who have vs. subjects who have not exhibited the adverse event. For each respective adverse event category, to present summary statistics of cobalt and chromium ion levels for subjects who have vs. subjects who have not exhibited the adverse event, stratified by post-op time cohort.
Measured: Through 8 years post-operatively
Trending
Trends (over time since initial implant) will be evaluated for: 1) revisions (survivorship), 2) adverse events, 3) pain or functional symptoms (via Harris Hip and HOOS evaluations), 4) incidence of ALTR in unrevised subjects
Measured: Through 8 years post-operatively
Patient history and demographics and association with outcomes
Patient demographic and subject history will be evaluated for association with: 1) higher metal ion levels and 2) risk of revision.
Measured: Throughout 8 years post-operatively
Modes and causes of implant failure
To evaluate modes and causes of implant failure based on an analysis of reasonably available explanted retrieved devices.
Measured: Through 8 years post-operatively
Metal ion levels and association with reason for revision
To compare cobalt and chromium levels across the different reasons for revision.
Measured: Through 8 years post-operatively
Comparison of metal ion levels across subjects with vs. without ALTR
Cobalt and Chromium ion levels will be compared for unrevised subjects who were not diagnosed with an ALTR vs. unrevised subject who were diagnosed with an ALTR.
Measured: Through 8 years post-operatively
Ion level vs. baseline for ALTR subjects
To compare cobalt and chromium ion level vs. baseline for subject who are diagnosed with ALTR.
Measured: Through 8 years post-operatively
Ion level change from first measurement for ALTR subjects
Cobalt and chromium ion levels will be compared from first measurement to the time of revision (prior to revision) or the time of last follow-up visit in the study, whichever comes first, for subjects who are diagnosed with an ALTR.
Measured: Through 8 years post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2016

First posted11 Apr 2013 (estimated)
Study startMar 2013
Primary completionNov 2015
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pinnacle Metal-on-MetalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828801
Sponsor's protocol ID: 10017
Status last verified: May 2016
First submitted: 2 Apr 2013
Last updated: 26 Sep 2016
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for Pinnacle MoM System Used in Primary Hip Arthroplasty
ClinicalTrials.gov ID: NCT01828801
Acronym / sponsor ID: 10017
Conditions: Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions, Total Hip Arthroplasty
Keywords: Adverse Local Tissue Reaction, Metal Ions, Serum, Whole Blood, Metal-on-Metal, Total Hip Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Nov 2015 (actual)
Study completion: Aug 2016 (actual)
First posted: 11 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 9

Arm	Type	Receives
Pre-Op	–	–Pre-operative patients who will undergo a total hip replacement.
1 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
2 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
3 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
4 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
5 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
6 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
7 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.
8 year post-op	–	Device: Pinnacle Metal-on MetalPatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients that have undergone a total hip arthroplasty with the Pinnacle Metal-on-Metal device within the past 8 years.

Key inclusion criteria (12 listed)

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):
Subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views:

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pinnacle Metal-on MetalAlso: Pinnacle MoM, UltametAll patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device	Device	1 year post-op, 2 year post-op, 3 year post-op, 4 year post-op, 5 year post-op, 6 year post-op, 7 year post-op, 8 year post-op

Primary outcome

Change in Chromium serum ion level across time intervals
Time frame: Pre-operatively through 8 years
To compare the chromium serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Change in Chromium whole blood ion level across time intervals
Time frame: Pre-operatively through 8 years
To compare the chromium whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Change in Cobalt serum ion level across time intervals
Time frame: Pre-operatively through 8 years
To compare the cobalt serum ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.
Change in Cobalt whole blood ion level across time intervals
Time frame: Pre-operatively through 8 years
To compare the cobalt whole blood ion levels in the patient population from pre-operatively through 8 years post-operatively in a 1-way ANOVA. This is a cross-sectional study so each time interval (pre-operatively through 8 years post-operatively) will be a different cohort of patients.

14 secondary outcomes

Poolability of data across stem types
Time frame: Pre-operatively through 8 years post-operatively
Incidence of adverse local tissue reaction (ALTR)
Time frame: Pre-operatively through 8 years post-operatively
Implant survivorship
Time frame: Through 8 years post-operatively
To identify the incidence of ALTR among unrevised subjects
Time frame: Through 8 years post-operatively
Ion levels among revised subjects
Time frame: Pre-operatively through 8 years post-operatively
Harris Hip and HOOS analysis for pain, function and total score
Time frame: Though 8 years post-operatively
To determine the association of adverse events with elevated ion levels
Time frame: Through 8 years post-operatively
Trending
Time frame: Through 8 years post-operatively
Patient history and demographics and association with outcomes
Time frame: Throughout 8 years post-operatively
Modes and causes of implant failure
Time frame: Through 8 years post-operatively
Metal ion levels and association with reason for revision
Time frame: Through 8 years post-operatively
Comparison of metal ion levels across subjects with vs. without ALTR
Time frame: Through 8 years post-operatively
Ion level vs. baseline for ALTR subjects
Time frame: Through 8 years post-operatively
Ion level change from first measurement for ALTR subjects
Time frame: Through 8 years post-operatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary F Panozzo, BS study director

DePuy Synthes Joint Reconstruction

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pinnacle Metal-on-Metal and Revised Pinnacle Metal-on-Metal, run by DePuy Orthopaedics at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Chromium serum ion level across time intervals (time frame: Pre-operatively through 8 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.