- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208494
Metal on Metal Versus Ceramic on Metal Hip Replacement
August 6, 2013 updated by: DePuy Orthopaedics
Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components.
The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up).
Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.
Study Type
Interventional
Enrollment (Actual)
392
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, N6A 5A5
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Arkansas
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Little Rock, Arkansas, United States, 72203
- Foundation for Musculoskeletal Research and Education
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California
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Orange, California, United States, 92868
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Florida
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Palm Bay, Florida, United States, 32905
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North Carolina
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Charlotte, North Carolina, United States, 28207
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Ohio
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Cincinnati, Ohio, United States, 45236
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Virginia
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Alexandria, Virginia, United States, 22306
- Anderson Clinic
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Roanoke, Virginia, United States, 24018
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Washington
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Spokane, Washington, United States, 99218
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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
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery.
- Skeletally mature (tibial and femoral epiphyses are closed)
- Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease
- Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater
- Radiographic Parameters:
- X-Ray Evaluation confirms the presence of NIDJD
- Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants
- No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s)
- Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary
- Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD
Exclusion Criteria:
- Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months)
- THA required for the revision of a previously failed THA
- Suffering from inflammatory arthritis
- Prior prosthetic hip replacement
- Previous Girdlestone procedure or surgical fusion in the operative hip joint
- Above knee amputation of either the contralateral or ipsilateral leg
- Known allergy to metal (e.g. jewelry)
- The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
- Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
- Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease)
- Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol
- Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Previous treatment for renal disease
- Any systemic steroid therapy, excluding inhalers, within three months prior to surgery
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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Active Comparator: A
Ceramic-on-metal total hip implant
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Total hip replacement
Other Names:
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Active Comparator: B
Metal-on-metal total hip implant
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Total hip replacement
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Composite Success/Failure
Time Frame: At 24 months
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The composite success/failure of the implant was made up of radiographic, clinical and revision data.
Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating.
Clinical success was determined by a Harris Hip score equal to or greater than 80.
A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
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At 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Scott, MD, Orthopaedic Specialty Clinic
- Principal Investigator: Patrick G Kirk, MD
- Principal Investigator: Shekhar S Desai, MD
- Principal Investigator: Charles A Engh, Jr., MD, Anderson Clinic
- Principal Investigator: Ajai Cadambi, MD, Adult Orthopaedic Reconstruction Texas Hip and Knee Center
- Principal Investigator: C L Barnes, MD, Foundation for Musculoskeletal Research & Education
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
August 1, 2005
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
August 14, 2013
Last Update Submitted That Met QC Criteria
August 6, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03062
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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