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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: February 28, 2012
Last verified: February 2012
History of Changes
  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.


Condition Intervention Phase
Joint Diseases
 Device: Total Hip Replacement
Device: Total hip replacement
 Phase 4

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:

U.S. FDA Resources

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.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Pre-operative, 4 weeks, 3 months and 1, 2, 3 and 4 years. ] [ Designated as safety issue: No ]
  • Complication Rates [ Time Frame: On-going to end of study. ] [ Designated as safety issue: Yes ]

Enrollment: 390
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:

  • Non-inflammatory joint disease

Exclusion Criteria:

  • Inflammatory joint disease
  • Prior prosthetic hip
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208494

Locations
United States, Indiana
DePuy Orthopaedics
Warsaw, Indiana, United States, 46581
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: February 28, 2012
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 May 22, 2013