Systemic Effects of Chronic Metal Ion Exposure From Metal-on Metal Hip Resurfacing

NCT01493141 | Completed

• 1 other identifier: STH15402
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years hip resurfacing has become a very popular alternative treatment to total hip replacement for the treatment of hip arthritis. This procedure has become particularly common in the young patient with arthritis because of perceived benefits in terms of functional outcome. However, it has recently become apparent that hip resurfacing is associated with a range of adverse events, not typically seen in patients with conventional hip replacement. These include hip fracture, and failure of bone to grow onto the fixation surfaces of the implant. It has also become apparent that hip resurfacing results in the release of high concentrations of dissolved metals in the bloodstream, such as cobalt and chromium. Whilst small concentrations of these metals are essential for normal body functions, such as making red blood cells, in high concentrations their effects can be toxic to many cells and organs of the body, such as bone, the brain, heart, liver and kidneys, as well as disturbing hormones and blood cholesterol levels. Whilst several studies have documented levels of these metal ions of 440 times normal levels in hip resurfacing patients, there are no studies that have examined whether these levels are having a toxic effect on the various organ systems of the body (with the exception of renal function). In this study we plan to explore whether there are differences in bone mineral density, accumulation of metal ions in the brain, and other solid organs, heart and hormonal function between subjects who have had a hip resurfacing 5 or more years previously compared to an individually matched group of subjects after conventional hip replacement.

Conditions

Osteoarthritis

Keywords

MOMHR; THA; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Difference in whole body bone mineral density measured by DXA between patients with MOMHR compared to conventional hip arthroplasty

  >5 years after procedure

Secondary Outcomes (11)

• Serum and urine biochemical markers of osteoclast and osteoblast activity.

  >5 years after procedure

• Serum, erythrocyte, and whole blood cobalt and chromium levels, measured by inductively-coupled plasma mass spectrometry (ICP MS)

  >5 years after procedure

• 24 hour urinary excretion of cobalt and chromium, measured by ICP MS

  >5 years after procedure

• Metal ion deposition in solid organs including the brain, liver and kidneys identified by MRI

  >5 years after procedure

• Cognitive function and visual acuity

  >5 years after procedure

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All potential subjects will be identified from the clinical records and registered databases of Mr Wilkinson and Mr Stockley, who are the clinicians who have been directly responsible for the patients clinical care with respect to their hip arthritis.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following markers will be measured using the blood samples: 1. Serum, erythrocyte, and whole blood cobalt, chromium, and nickel 2. Serum iron stores: Iron, ferritin, transferrin, and total iron binding capacity. 3. Serum biochemical markers of bone turnover: Osteoblast activity markers (including PINP, OC, BALP) Osteoclast activity markers (including NTX-I, CTX-I, ICTP) 4. Hypothalamo-pituitary axis hormones (in the following order of priority): Prolactin LH/FSH + testosterone/oestradiol Growth hormone + IGF-I TSH + Free T3 ACTH + cortisol 5. Renal function: Urea, electrolytes, and creatinine 6. Hepatic function Liver function tests Clotting screen 7. Serum lipid profile, full blood count

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark JM Wilkinson, Prof

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 15, 2011
• Study Start: November 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

GB (1)