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Metal on Metal Versus Ceramic on Metal Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208494
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 4, 2011
Last Update Posted : August 14, 2013
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-inflammatory Joint Diseases Device: Total Hip Replacement Device: Total hip replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
Ceramic-on-metal total hip implant
Device: Total Hip Replacement
Total hip replacement
Other Name: Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell

Active Comparator: B
Metal-on-metal total hip implant
Device: Total hip replacement
Total hip replacement
Other Name: CoCr M-head, Ultamet insert, Pinnacle Acetabular shell

Primary Outcome Measures :
  1. Composite Success/Failure [ Time Frame: At 24 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00208494

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United States, Arkansas
Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, United States, 72203
United States, California
Orange, California, United States, 92868
United States, Florida
Palm Bay, Florida, United States, 32905
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati, Ohio, United States, 45236
United States, Virginia
Anderson Clinic
Alexandria, Virginia, United States, 22306
Roanoke, Virginia, United States, 24018
United States, Washington
Spokane, Washington, United States, 99218
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
DePuy Orthopaedics
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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

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Responsible Party: DePuy Orthopaedics Identifier: NCT00208494    
Other Study ID Numbers: 03062
First Posted: September 21, 2005    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: August 14, 2013
Last Verified: August 2013
Keywords provided by DePuy Orthopaedics:
Non-Inflammatory Degenerative Joint Disease
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases