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Cardiac MRI for Metal on Metal Hip Resurfacing

Cardiac MRI for Metal on Metal Orthopaedic Prostheses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02892448
Acronym
CardiacMRI
Enrollment
35
Registered
2016-09-08
Start date
2016-09-30
Completion date
2019-07-20
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy

Brief summary

There may be a relationship between heart function and the metal ion levels in patients having undergone total hip replacement. The idea is to use results from a clinical cardiac MRI to assess heart function in a sample of 30 patients whom have undergone either metal-on-metal hip replacement (unilateral or bilateral) or a non-metal on metal total hip replacement to determine whether having undergone a metal on metal hip procedure may be impacting heart function. In addition to the clinically used parameters, the images will also be retrospectively assessed using special software to assess amount of fibrosis and early changes affecting cardiac muscle contraction which may be indicative of impaired heart function. With these values we will compare to known, and previously collected, hip replacement and function data to determine whether there is any differences in how the heart works in those having had a hip replacement relative to a normal population.

Detailed description

There has been some recent concern regarding possible systemic health effects resulting from elevated blood cobalt concentrations in patients with cobalt containing hip implants (1). To date there are no blood cobalt criteria to help guide physicians when evaluating an individual hip implant patient's risk of developing systemic health effects because historically there was little or no concern about systemic cobalt toxicity in implant patients. Included within this is heart function, for which investigators see a need to use this novel software to analyze heart function relative to Hip status and Metal Ion levels. Patients with metal on metal hip prosthesis are subject to local and systemic release of cobalt and chromium ions which may increase the potential for locally aggressive ion-induced local tissue reactions such as pseudotumours, a type of Adverse Reaction to Metal Debris (ARMD) (2). Although there have been reports of local toxicity as well as cases of cobaltism (as seen during outbreak in Quebec of so called 'cobalt beer drinkers' cardiomyopathy) leading to cardiac and ototoxicity, it is unclear if chronic exposure to these ions can lead to impaired cardiac function (cardiotoxicity) in a well-functioning prosthesis. The majority of the blood cobalt concentrations reported for hip implant patients appear to range from approximately 0.2 to 10 µg/L, and based on our review of the available literature, should not pose an increased risk for the development of systemic health effects. The concern for systemic health effects is for the small number of patients with cobalt-containing hip implants with markedly elevated blood cobalt concentrations. Extensive evaluations of these 'cobalt beer drinkers' have found that poor nutrition and underlying disease states caused by severe alcoholism were likely significant contributing factors to heart disease in this particular population. However, there remains a significant concern that cardiac function could be affected in the long term. This is especially relevant as the majority of these implants are put in patients less than 50 years age. Cardiac magnetic resonance imaging (CMR) is the gold standard method to assess cardiac function in patients at risk of cardiotoxicity. In addition to assessing cardiac function, CMR enables imaging of inflammation, and fibrosis (which may be secondary to the ion deposition) in the heart which may provide more specific information about the mechanism of injury in these patients. The purpose of this study is to look at cardiac function in patients with a metal on metal hip prostheses. Recruitment: 30 patients in total (10 unilateral and 10 bilateral hip resurfacing patients and 10 non-metal on metal total hip replacement patients) will be recruited which should provide indication of relationship both between either instances and heart function, as well as compared to one another. All patients will be undergoing clinical cardiac MRI. All patients will have extra images collected during their MRI and these images will be analyzed to determine any relationship between heart function and the possible metal ion levels from the hip implant. As part of the scan analysis they will be required to also have a 5 millilitres (mLs) vial of blood collected. Ultrasound values will be retrospectively collected, for analysis of soft tissue reaction, from a previous clinically ordered ultrasound of the affected joint.

Interventions

Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.

Sponsors

Ottawa Heart Institute Research Corporation
CollaboratorOTHER
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Undergoing clinical Cardiac MRI * Currently enrolled with either unilateral or bilateral metal-on-metal (MoM) Hip replacement device * Willing to sign Informed Consent Form

Exclusion criteria

* Patient does not meet all 'inclusion' criteria

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Ejection FractionMinimum 5 years post-operativeThe volumetric fraction of fluid ejected from a chamber with each contraction.
Comprehensive Cardiac FunctionOne time measure at CMRVolume measures including: left ventricular end-diastolic volume, left ventricular stroke volume, right ventricular end-diastolic volume, right ventricular end-systolic volume, right ventricular stroke volume
T2* Mapping TimeOne time measure at CMRT2\* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
T1 Mapping TimeOne time measure at CMRT1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.

Secondary

MeasureTime frameDescription
Cobalt and Chromium Ion LevelsImmediately Prior to cardiac MRITo measure the level of cobalt and chromium ions in blood

Countries

Canada

Participant flow

Participants by arm

ArmCount
Unilateral Hip Resurfacing
Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.
10
Bilateral Hip Resurfacing
Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.
10
Non-Metal on Metal Total Hip
Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Cardiac magnetic resonance imaging (CMR): Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.
10
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyScreening failure221

Baseline characteristics

CharacteristicUnilateral Hip ResurfacingBilateral Hip ResurfacingNon-Metal on Metal Total HipTotal
Age, Continuous59.4 years57.7 years58.4 years58.5 years
Body Mass Index (BMI)28.1 kg/m^229.0 kg/m^227.1 kg/m^228.1 kg/m^2
Body Surface Area (BSA)2.04 m^22.08 m^21.97 m^22.03 m^2
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
1 Participants2 Participants4 Participants7 Participants
Sex: Female, Male
Male
9 Participants8 Participants6 Participants23 Participants
Time since implantation9.1 years7.5 years6.7 years7.8 years

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 10

Outcome results

Primary

Cardiac Ejection Fraction

The volumetric fraction of fluid ejected from a chamber with each contraction.

Time frame: Minimum 5 years post-operative

ArmMeasureGroupValue (MEAN)
Unilateral Hip ResurfacingCardiac Ejection FractionLeft ventricular ejection fraction64 Percent
Unilateral Hip ResurfacingCardiac Ejection FractionRight ventricular ejecton fraction62 Percent
Bilateral Hip ResurfacingCardiac Ejection FractionLeft ventricular ejection fraction66 Percent
Bilateral Hip ResurfacingCardiac Ejection FractionRight ventricular ejecton fraction63 Percent
Non-Metal on Metal Total HipCardiac Ejection FractionLeft ventricular ejection fraction65 Percent
Non-Metal on Metal Total HipCardiac Ejection FractionRight ventricular ejecton fraction62 Percent
Primary

Comprehensive Cardiac Function

Volume measures including: left ventricular end-diastolic volume, left ventricular stroke volume, right ventricular end-diastolic volume, right ventricular end-systolic volume, right ventricular stroke volume

Time frame: One time measure at CMR

ArmMeasureGroupValue (MEAN)
Unilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle end-diastolic volume (LVEDV)77 mL/m^2
Unilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle end-systolic volume (LVESV)27 mL/m^2
Unilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle stroke volume (LVSV)51 mL/m^2
Unilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle end-diastolic volume (RVEDV)79 mL/m^2
Unilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle end-systolic volume (RVESV)30 mL/m^2
Unilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle stroke volume (RVSV)53 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle stroke volume (RVSV)50 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle end-diastolic volume (LVEDV)73 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle end-diastolic volume (RVEDV)82 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionRight ventricle end-systolic volume (RVESV)30 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle end-systolic volume (LVESV)26 mL/m^2
Bilateral Hip ResurfacingComprehensive Cardiac FunctionLeft ventricle stroke volume (LVSV)46 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionLeft ventricle end-systolic volume (LVESV)23 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionLeft ventricle stroke volume (LVSV)43 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionRight ventricle stroke volume (RVSV)43 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionRight ventricle end-diastolic volume (RVEDV)71 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionLeft ventricle end-diastolic volume (LVEDV)67 mL/m^2
Non-Metal on Metal Total HipComprehensive Cardiac FunctionRight ventricle end-systolic volume (RVESV)28 mL/m^2
Primary

T1 Mapping Time

T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.

Time frame: One time measure at CMR

ArmMeasureGroupValue (MEAN)
Unilateral Hip ResurfacingT1 Mapping TimeNative T1 left ventricle (LV) average1003 ms
Unilateral Hip ResurfacingT1 Mapping TimePost gadolinium T1 left ventricle (LV) average402 ms
Bilateral Hip ResurfacingT1 Mapping TimeNative T1 left ventricle (LV) average988 ms
Bilateral Hip ResurfacingT1 Mapping TimePost gadolinium T1 left ventricle (LV) average409 ms
Non-Metal on Metal Total HipT1 Mapping TimeNative T1 left ventricle (LV) average993 ms
Non-Metal on Metal Total HipT1 Mapping TimePost gadolinium T1 left ventricle (LV) average383 ms
Primary

T2* Mapping Time

T2\* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.

Time frame: One time measure at CMR

ArmMeasureGroupValue (MEAN)
Unilateral Hip ResurfacingT2* Mapping TimeMyocardium32 ms
Unilateral Hip ResurfacingT2* Mapping TimeLiver27 ms
Bilateral Hip ResurfacingT2* Mapping TimeMyocardium33 ms
Bilateral Hip ResurfacingT2* Mapping TimeLiver24 ms
Non-Metal on Metal Total HipT2* Mapping TimeMyocardium33 ms
Non-Metal on Metal Total HipT2* Mapping TimeLiver28 ms
Secondary

Cobalt and Chromium Ion Levels

To measure the level of cobalt and chromium ions in blood

Time frame: Immediately Prior to cardiac MRI

ArmMeasureGroupValue (MEAN)
Unilateral Hip ResurfacingCobalt and Chromium Ion LevelsCobat blood levels0.71 ug/L
Unilateral Hip ResurfacingCobalt and Chromium Ion LevelsChromium blood levels1.41 ug/L
Bilateral Hip ResurfacingCobalt and Chromium Ion LevelsCobat blood levels1.47 ug/L
Bilateral Hip ResurfacingCobalt and Chromium Ion LevelsChromium blood levels2.58 ug/L
Non-Metal on Metal Total HipCobalt and Chromium Ion LevelsChromium blood levels0.11 ug/L
Non-Metal on Metal Total HipCobalt and Chromium Ion LevelsCobat blood levels0.18 ug/L

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026