Text Size

Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Western Ontario, Canada
DePuy Orthopaedics
Information provided by (Responsible Party):
C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT00962351
First received: August 19, 2009
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.


Condition Intervention
Non-inflammatory Degenerative Joint Disease
 Procedure: Total Hip Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • cobalt, chromium, and titanium ion levels in blood and urine [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hip function [ Time Frame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years ] [ Designated as safety issue: No ]
  • Durability [ Time Frame: 6 months, 1 year, 2 years, 3 years, 5 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2003
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Metal-on-Polyethylene Procedure: Total Hip Replacement
Metal-on-Metal, 28mm femoral head Procedure: Total Hip Replacement
Metal-on-Metal, 36mm femoral head Procedure: Total Hip Replacement

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing cementless primary total hip replacement
  • Receiving acetabular cup of 52mm or greater
  • Preoperative level of function and pain same as for conventional hip replacement
  • Likelihood of obtaining relief of pain and improved function
  • Full skeletal maturity
  • Ability to follow instructions
  • Good general health
  • Willing to return for follow-up evaluations
  • X-ray evaluation confirming the presence of NIDJD
  • Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

Exclusion Criteria:

  • Age less than 40 years or greater than 80 years at time of surgery
  • Patients templated to receive an acetabular component smaller than 52mm in diameter
  • Presence of a previous prosthetic hip replacement device in the hip joint to be operated
  • Previous girdlestone procedure or surgical fusion of the hip to be operated
  • Acute femoral neck fracture
  • Above knee amputation of the contralateral and/or ipsilateral leg
  • Patients with a diagnosis of inflammatory degenerative arthritis
  • Skeletally immature
  • Evidence of active infections that may spread to other areas of the body
  • The presence of a highly communicable disease that may limit follow-up
  • Presence of known active metastatic or neoplastic disease
  • Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
  • Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
  • Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
  • Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
  • Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
  • Any steroid therapy, local or systemic, within three months prior to surgery
  • Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
  • Patient has known allergies to metal, e.g., jewelry
  • Any patient not meeting all radiographic and clinical parameters for inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962351

Locations
United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22306
Canada, Ontario
Department of Orthopaedic Surgery, University of Western Ontario
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
University of Western Ontario, Canada
DePuy Orthopaedics
Investigators
Principal Investigator: C. Anderson Engh, Jr., MD Anderson Orthopaedic Research Institute
Principal Investigator: Steven J. MacDonald, MD University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: C. Anderson Engh, Jr., MD, Orthopaedic Surgeon, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT00962351     History of Changes
Other Study ID Numbers: AORI2009-0100
Study First Received: August 19, 2009
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
total hip replacement
primary cementless total hip arthroplasty
metal ion
metal-on-metal

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013