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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

August 19, 2009
February 1, 2013
October 2003
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00962351 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Non-inflammatory Degenerative Joint Disease
Procedure: Total Hip Replacement
  • Metal-on-Polyethylene
    Intervention: Procedure: Total Hip Replacement
  • Metal-on-Metal, 28mm femoral head
    Intervention: Procedure: Total Hip Replacement
  • Metal-on-Metal, 36mm femoral head
    Intervention: Procedure: Total Hip Replacement
Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. Epub 2008 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00962351
AORI2009-0100
Yes
C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
Anderson Orthopaedic Research Institute
  • University of Western Ontario, Canada
  • DePuy Orthopaedics
Principal Investigator: C. Anderson Engh, Jr., MD Anderson Orthopaedic Research Institute
Principal Investigator: Steven J. MacDonald, MD University of Western Ontario, Canada
Anderson Orthopaedic Research Institute
February 2013

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