- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493141
Systemic Effects of Chronic Metal Ion Exposure From Metal-on Metal Hip Resurfacing (Metal Ions)
Study Overview
Status
Conditions
Detailed Description
This is a cross sectional survey in patients who have had hip resurfacing (MOMHR) and subjects who have received a conventional hip replacement (THA) using a metal on plastic or ceramic bearing. Participants in this study will be identified by orthopaedic surgeons from their operating database. An invitation letter will be sent out to the potential participants with an accompanying information sheet and a reply slip. If there is no response then one further letter will be sent out. Those patients who respond to say that they are interested in taking part in the study will then be telephoned by the study team and screened for inclusion/exclusion criteria. If they are eligible and willing to take part after discussions with the investigator, an appointment will be made for them to attend to give informed consent. Participants will be requested not to eat or drink on the morning that they attend for this visit.
There will be an opportunity at this visit for further discussion and explanation of the study requirements with the Investigator before consent is given.
Once consent has been given, the following procedures will be carried out at this visit (Visit 1):
- Venous blood will be taken by venepuncture (60 mL, approx 4 tablespoons, will be taken) after which the participant will be able to eat breakfast (which will be provided).
- A urine based pregnancy test will be used in women of child bearing age to exclude pregnant women
- Participants will complete the Oxford Hip questionnaire, the EQ5D questionnaire and a record of medical history and concomitant medicines under supervision of the student investigator or an experienced research nurse.
- Whole body bone mineral density assessments will be made using an Hologic Discovery bone densitometer. This will take approximately 10 minutes in total and will be carried out by an experienced research bone density technician
- An electrocardiogram and an echocardiogram will be performed by an experienced cardiotechnician and later analysed by a Consultant Cardiologist
- Participants will be given a container and instructions to collect a 24 hour urine sample. This will be returned at the second visit
- An appointment will be made for the participant to attend for a second visit to the Royal Hallamshire Hospital.
At visit 2 the following procedures will be carried out:
- Neuropsychological assessments and questionnaires and visual acuity measurement using a Snellen chart.
- Magnetic resonance imaging (MRI) of the brain using a 3.0T Phillips Intera MRI scanner.
- MRI of the liver spleen and kidneys using the 3.0T Phillips Intera MRI scanner. Clinical reports will be prepared for all clinical investigations and normal findings will be related to the patient by letter.
Abnormal findings will be reported to the GP and patient with advice for any action as necessary.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- MOMHR subjects - 35 Men and women at a minimum of 5 years following unilateral or bilateral MOMHR for primary or secondary OA
- Conventional THA subjects - These subjects will be individually (casebycase) matched with MOMHR subjects for age (±3 years), sex, and year of primary arthroplasty surgery (±2 years).
Exclusion Criteria:
- Known inflammatory arthropathy or metabolic bone disease.
- Use of pharmacological doses of estrogen, progestin, androgen, calcitonin, glucocorticoids, or dietary supplements of calcium or vitamin D within the previous 12 months
- Any previous use of bisphosphonate or fluoride therapy (excluding dental prophylaxis)
- Pregnancy
- Subjects who cannot undergo an MRI scan for medical reasons e.g. those with a cardiac pacemaker
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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MOMHR
Patients who have had metal-on metal hip resurfacing (MOMHR)
|
THA
Patients who have had metal-on-polyethylene or ceramic total hip arthroplasty (THA)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in whole body bone mineral density measured by DXA between patients with MOMHR compared to conventional hip arthroplasty
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum and urine biochemical markers of osteoclast and osteoblast activity.
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Serum, erythrocyte, and whole blood cobalt and chromium levels, measured by inductively-coupled plasma mass spectrometry (ICP MS)
Time Frame: >5 years after procedure
|
>5 years after procedure
|
24 hour urinary excretion of cobalt and chromium, measured by ICP MS
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Metal ion deposition in solid organs including the brain, liver and kidneys identified by MRI
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Cognitive function and visual acuity
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Cardiac function, measured by transthoracic echocardiography and electrocardiogram
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Renal function measured by serum creatinine, urinary creatinine clearance, urinary N-acetyl-β-D-glucosaminidase (NAG) and Kidney Injury Molecule-1 (Kim-1)
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Hepatic function measured by liver function tests and clotting screen
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Endocrine function measured by assessment of hypathalamo-pituitary axis hormones
Time Frame: >5 years after procedure
|
>5 years after procedure
|
Serum lipid profile and polycythemia, measured by serum triglycerides, cholesterol, and full blood count
Time Frame: >5 years after procedure
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>5 years after procedure
|
Clinical hip replacement function measured by Oxford hip score and EQ-5D
Time Frame: >5 years after procedure
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>5 years after procedure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark JM Wilkinson, Prof, University of Sheffield
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH15402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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