Metal on Metal Versus Ceramic on Metal Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT00208494
First received: September 13, 2005
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention
Non-inflammatory Joint Diseases
Device: Total Hip Replacement
Device: Total hip replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Composite Success/Failure [ Time Frame: At 24 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 392
Study Start Date: August 2005
Study Completion Date: June 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208494

Locations
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
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
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT00208494     History of Changes
Other Study ID Numbers: 03062
Study First Received: September 13, 2005
Results First Received: July 11, 2011
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Non-Inflammatory Degenerative Joint Disease

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014