Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
August 14, 2015 updated by: C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A5A5
- Department of Orthopaedic Surgery, University of Western Ontario
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Virginia
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Alexandria, Virginia, United States, 22306
- Anderson Orthopaedic Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Undergoing cementless primary total hip replacement
- Receiving acetabular cup of 52mm or greater
- Preoperative level of function and pain same as for conventional hip replacement
- Likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
- Ability to follow instructions
- Good general health
- Willing to return for follow-up evaluations
- X-ray evaluation confirming the presence of NIDJD
- Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants
Exclusion Criteria:
- Age less than 40 years or greater than 80 years at time of surgery
- Patients templated to receive an acetabular component smaller than 52mm in diameter
- Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- Previous girdlestone procedure or surgical fusion of the hip to be operated
- Acute femoral neck fracture
- Above knee amputation of the contralateral and/or ipsilateral leg
- Patients with a diagnosis of inflammatory degenerative arthritis
- Skeletally immature
- Evidence of active infections that may spread to other areas of the body
- The presence of a highly communicable disease that may limit follow-up
- Presence of known active metastatic or neoplastic disease
- Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
- Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
- Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
- Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
- Any steroid therapy, local or systemic, within three months prior to surgery
- Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
- Patient has known allergies to metal, e.g., jewelry
- Any patient not meeting all radiographic and clinical parameters for inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Metal-on-Polyethylene
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Other: Metal-on-Metal, 28mm femoral head
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Other: Metal-on-Metal, 36mm femoral head
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cobalt, chromium, and titanium ion levels in blood and urine
Time Frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
|
Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Hip function
Time Frame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years
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Pre-op, 6 months,1 year, 2 years, 3 years, 5 years
|
|
Durability
Time Frame: 6 months, 1 year, 2 years, 3 years, 5 years
|
6 months, 1 year, 2 years, 3 years, 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven J. MacDonald, MD, Department of Orthopaedic Surgery, University of Western Ontario
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 19, 2009
First Submitted That Met QC Criteria
August 19, 2009
First Posted (Estimate)
August 20, 2009
Study Record Updates
Last Update Posted (Estimate)
August 17, 2015
Last Update Submitted That Met QC Criteria
August 14, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AORI2009-0100
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.