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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE July 11, 2011
Results First Posted Date  ICMJE August 4, 2011
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Change History Complete list of historical versions of study NCT00208494 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Harris Hip, Complication Rates
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Metal on Metal Versus Ceramic on Metal Hip Replacement
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Non-inflammatory Joint Diseases
Intervention  ICMJE
  • Device: Total Hip Replacement
    Total hip replacement
    Other Name: Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell
  • Device: Total hip replacement
    Total hip replacement
    Other Name: CoCr M-head, Ultamet insert, Pinnacle Acetabular shell
Study Arms  ICMJE
  • Active Comparator: A
    Ceramic-on-metal total hip implant
    Intervention: Device: Total Hip Replacement
  • Active Comparator: B
    Metal-on-metal total hip implant
    Intervention: Device: Total hip replacement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2013)
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00208494
Other Study ID Numbers  ICMJE 03062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DePuy Orthopaedics
Study Sponsor  ICMJE DePuy Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account DePuy Orthopaedics
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP