Systemic Effects of Chronic Metal Ion Exposure From Metal-on Metal Hip Resurfacing (Metal Ions)
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|ClinicalTrials.gov Identifier: NCT01493141|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : December 17, 2012
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||46 participants|
|Official Title:||Systemic Effects of Chronic Metal Ion Exposure From Metal-on Metal Hip Resurfacing|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Patients who have had metal-on metal hip resurfacing (MOMHR)
Patients who have had metal-on-polyethylene or ceramic total hip arthroplasty (THA)
- 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 ]
- Serum and urine biochemical markers of osteoclast and osteoblast activity. [ Time Frame: >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 ]
- 24 hour urinary excretion of cobalt and chromium, measured by ICP MS [ Time Frame: >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 ]
- Cognitive function and visual acuity [ Time Frame: >5 years after procedure ]
- Cardiac function, measured by transthoracic echocardiography and electrocardiogram [ Time Frame: >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 ]
- Hepatic function measured by liver function tests and clotting screen [ Time Frame: >5 years after procedure ]
- Endocrine function measured by assessment of hypathalamo-pituitary axis hormones [ Time Frame: >5 years after procedure ]
- Serum lipid profile and polycythemia, measured by serum triglycerides, cholesterol, and full blood count [ Time Frame: >5 years after procedure ]
- Clinical hip replacement function measured by Oxford hip score and EQ-5D [ Time Frame: >5 years after procedure ]
Biospecimen Retention: Samples With DNA
The following markers will be measured using the blood samples:
- Serum, erythrocyte, and whole blood cobalt, chromium, and nickel
Serum iron stores:
Iron, ferritin, transferrin, and total iron binding capacity.
Serum biochemical markers of bone turnover:
Osteoblast activity markers (including PINP, OC, BALP) Osteoclast activity markers (including NTX-I, CTX-I, ICTP)
Hypothalamo-pituitary axis hormones (in the following order of priority):
Prolactin LH/FSH + testosterone/oestradiol Growth hormone + IGF-I TSH + Free T3 ACTH + cortisol
Urea, electrolytes, and creatinine
- Hepatic function Liver function tests Clotting screen
- Serum lipid profile, full blood count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493141
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S5 7AU|
|Principal Investigator:||Mark JM Wilkinson, Prof||University of Sheffield|