Trial Outcomes & Findings for Cardiac MRI for Metal on Metal Hip Resurfacing (NCT NCT02892448)
NCT ID: NCT02892448
Last Updated: 2020-08-24
Results Overview
The volumetric fraction of fluid ejected from a chamber with each contraction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Minimum 5 years post-operative
Results posted on
2020-08-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Screening failure
|
2
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.4 years
n=10 Participants
|
57.7 years
n=10 Participants
|
58.4 years
n=10 Participants
|
58.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
23 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Time since implantation
|
9.1 years
n=10 Participants
|
7.5 years
n=10 Participants
|
6.7 years
n=10 Participants
|
7.8 years
n=30 Participants
|
|
Body Mass Index (BMI)
|
28.1 kg/m^2
n=10 Participants
|
29.0 kg/m^2
n=10 Participants
|
27.1 kg/m^2
n=10 Participants
|
28.1 kg/m^2
n=30 Participants
|
|
Body Surface Area (BSA)
|
2.04 m^2
n=10 Participants
|
2.08 m^2
n=10 Participants
|
1.97 m^2
n=10 Participants
|
2.03 m^2
n=30 Participants
|
PRIMARY outcome
Timeframe: Minimum 5 years post-operativeThe volumetric fraction of fluid ejected from a chamber with each contraction.
Outcome measures
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
|---|---|---|---|
|
Cardiac Ejection Fraction
Left ventricular ejection fraction
|
64 Percent
Interval 60.0 to 69.0
|
66 Percent
Interval 63.0 to 72.0
|
65 Percent
Interval 59.0 to 70.0
|
|
Cardiac Ejection Fraction
Right ventricular ejecton fraction
|
62 Percent
Interval 60.0 to 64.0
|
63 Percent
Interval 58.0 to 70.0
|
62 Percent
Interval 60.0 to 64.0
|
PRIMARY outcome
Timeframe: One 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
Outcome measures
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
|---|---|---|---|
|
Comprehensive Cardiac Function
Left ventricle end-diastolic volume (LVEDV)
|
77 mL/m^2
Interval 68.0 to 80.0
|
73 mL/m^2
Interval 65.0 to 85.0
|
67 mL/m^2
Interval 61.0 to 70.0
|
|
Comprehensive Cardiac Function
Left ventricle end-systolic volume (LVESV)
|
27 mL/m^2
Interval 20.0 to 39.0
|
26 mL/m^2
Interval 23.0 to 29.0
|
23 mL/m^2
Interval 19.0 to 29.0
|
|
Comprehensive Cardiac Function
Left ventricle stroke volume (LVSV)
|
51 mL/m^2
Interval 42.0 to 56.0
|
46 mL/m^2
Interval 41.0 to 62.0
|
43 mL/m^2
Interval 41.0 to 46.0
|
|
Comprehensive Cardiac Function
Right ventricle end-diastolic volume (RVEDV)
|
79 mL/m^2
Interval 76.0 to 87.0
|
82 mL/m^2
Interval 76.0 to 84.0
|
71 mL/m^2
Interval 64.0 to 77.0
|
|
Comprehensive Cardiac Function
Right ventricle end-systolic volume (RVESV)
|
30 mL/m^2
Interval 22.0 to 35.0
|
30 mL/m^2
Interval 24.0 to 31.0
|
28 mL/m^2
Interval 22.0 to 31.0
|
|
Comprehensive Cardiac Function
Right ventricle stroke volume (RVSV)
|
53 mL/m^2
Interval 46.0 to 57.0
|
50 mL/m^2
Interval 41.0 to 56.0
|
43 mL/m^2
Interval 41.0 to 46.0
|
PRIMARY outcome
Timeframe: One time measure at CMRT2\* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Outcome measures
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
|---|---|---|---|
|
T2* Mapping Time
Myocardium
|
32 ms
Interval 32.0 to 34.0
|
33 ms
Interval 32.0 to 34.0
|
33 ms
Interval 30.0 to 37.0
|
|
T2* Mapping Time
Liver
|
27 ms
Interval 23.0 to 29.0
|
24 ms
Interval 15.0 to 26.0
|
28 ms
Interval 27.0 to 30.0
|
PRIMARY outcome
Timeframe: One time measure at CMRT1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Outcome measures
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
|---|---|---|---|
|
T1 Mapping Time
Native T1 left ventricle (LV) average
|
1003 ms
Interval 988.0 to 1014.0
|
988 ms
Interval 980.0 to 997.0
|
993 ms
Interval 987.0 to 1007.0
|
|
T1 Mapping Time
Post gadolinium T1 left ventricle (LV) average
|
402 ms
Interval 384.0 to 432.0
|
409 ms
Interval 402.0 to 418.0
|
383 ms
Interval 371.0 to 397.0
|
SECONDARY outcome
Timeframe: Immediately Prior to cardiac MRITo measure the level of cobalt and chromium ions in blood
Outcome measures
| Measure |
Unilateral Hip Resurfacing
n=10 Participants
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.
|
Bilateral Hip Resurfacing
n=10 Participants
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.
|
Non-Metal on Metal Total Hip
n=10 Participants
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.
|
|---|---|---|---|
|
Cobalt and Chromium Ion Levels
Cobat blood levels
|
0.71 ug/L
Interval 0.5 to 1.07
|
1.47 ug/L
Interval 1.33 to 2.16
|
0.18 ug/L
Interval 0.16 to 0.19
|
|
Cobalt and Chromium Ion Levels
Chromium blood levels
|
1.41 ug/L
Interval 0.97 to 2.0
|
2.58 ug/L
Interval 1.6 to 2.9
|
0.11 ug/L
Interval 0.1 to 1.8
|
Adverse Events
Unilateral Hip Resurfacing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bilateral Hip Resurfacing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Metal on Metal Total Hip
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paul E Beaule
The Ottawa Hospital Research Institute
Phone: 613-737-8899
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place