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

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.
ClinicalTrials.gov Identifier: NCT00962351
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : August 17, 2015
Sponsor:
Collaborators:
University of Western Ontario, Canada
DePuy Orthopaedics
Information provided by (Responsible Party):
C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute

Tracking Information
First Submitted Date  ICMJE August 19, 2009
First Posted Date  ICMJE August 20, 2009
Last Update Posted Date August 17, 2015
Study Start Date  ICMJE October 2003
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
cobalt, chromium, and titanium ion levels in blood and urine [ Time Frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00962351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2009)
  • Hip function [ Time Frame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years ]
  • Durability [ Time Frame: 6 months, 1 year, 2 years, 3 years, 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
Official Title  ICMJE Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
Brief Summary 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.
Detailed Description Not Provided
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 Degenerative Joint Disease
Intervention  ICMJE Procedure: Total Hip Replacement
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2009)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 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 NCT00962351
Other Study ID Numbers  ICMJE AORI2009-0100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
Study Sponsor  ICMJE Anderson Orthopaedic Research Institute
Collaborators  ICMJE
  • University of Western Ontario, Canada
  • DePuy Orthopaedics
Investigators  ICMJE
Principal Investigator: C. Anderson Engh, Jr., MD Anderson Orthopaedic Research Institute
Principal Investigator: Steven J. MacDonald, MD University of Western Ontario, Canada
PRS Account Anderson Orthopaedic Research Institute
Verification Date August 2015

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