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N/A N=35 Other

Cardiac MRI for Metal on Metal Hip Resurfacing

Cardiomyopathy

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Cardiac Ejection Fraction — 64; 66; 65; 62 Percent

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cardiac magnetic resonance imaging (CMR) (Other)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Ottawa Hospital Research Institute
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Cardiac Ejection Fraction
64; 66; 65; 62; 63; 62
PRIMARY
Comprehensive Cardiac Function
77; 73; 67; 27; 26; 23
PRIMARY
T2* Mapping Time
32; 33; 33; 27; 24; 28
PRIMARY
T1 Mapping Time
1003; 988; 993; 402; 409; 383
SECONDARY
Cobalt and Chromium Ion Levels
1.41; 2.58; 0.11; 0.71; 1.47; 0.18

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02892448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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