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A Comparison of Two Type of Stems in Revision Hip Arthroplasty

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: NCT00253838
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 10, 2005
November 15, 2005
September 25, 2017
October 2001
September 2010   (Final data collection date for primary outcome measure)
Safety of surgical implant [ Time Frame: 24 months ]
Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery
bone mineral density scores
Complete list of historical versions of study NCT00253838 on ClinicalTrials.gov Archive Site
  • Patient outcome measures [ Time Frame: pre-op, 6, 12, 24, 60 months ]
    Patient outcome measures will be assessed using the SF-12 and WOMAC questionnaires.
  • Effectiveness of surgical implant [ Time Frame: 24 months ]
    The Harris Hip Score will be used to evaluate the effectiveness of the surgical implant
Rates of osteolysis/radiolucent lines on radiographs WOMAC SF-12 Harris Hip Score Rate of revision Rate of complication
Not Provided
Not Provided
 
A Comparison of Two Type of Stems in Revision Hip Arthroplasty
A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study
This study compares two different hip stem components. Both hip stems used in this study allow the femur bone to attach and grow into them for stability. The main difference between the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem included in the study, the Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer on the stem to encourage the bone to grow into it. We are trying to see if there is any difference in the initial bony ingrowth between the two stems and to compare the results in patients over the first two years after the surgery and then again at the five-year period.
Revision total hip arthroplasty is becoming increasingly common due to the large number of primary total hip arthroplasties being performed annually. Failure of these arthroplasties has led to an increasing number of patients requiring revision arthroplasty. Various methods have been used to reconstruct the hip during a revision procedure. These have generally consisted of a cemented or uncemented femoral stem. It is now generally accepted that uncemented femoral stems have improved results over cemented stems, especially in those cases with compromised bone stock. There are two main alloys used for the femoral revision component, that is cobalt chrome and titanium. There may be certain advantages to the use of titanium, in particular, a reduction in future bone loss caused by stress shielding. Stress shielding is commonly seen with cobalt chrome implants. In order to assess this and the overall survival of these two different implants a randomized clinical trial is proposed.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Hip Arthroplasty
  • Procedure: Restoration HA stem
    The Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surfacing and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem.
    Other Name: non applicable
  • Procedure: Solution stem
    The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
    Other Name: non applicable
  • Active Comparator: Restoration HA Stem
    The Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surfacing and allows for a hydroxylapatite (HA) coating
    Intervention: Procedure: Restoration HA stem
  • Sham Comparator: Solution stem
    The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
    Intervention: Procedure: Solution stem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
March 2012
September 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidates for revision hip arthropathy

Exclusion Criteria:

  • Under 21 years of age
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00253838
OHREB 2001215-01H
No
Not Provided
Not Provided
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Stryker Nordic
Principal Investigator: Paul R Kim, MD, FRCSC OHRI
Ottawa Hospital Research Institute
September 2017

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