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A Comparison of Two Type of Stems in Revision Hip Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253838
First Posted: November 15, 2005
Last Update Posted: September 25, 2017
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.
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
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.

Condition Intervention
Hip Arthroplasty Procedure: Restoration HA stem Procedure: Solution stem

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Safety of surgical implant [ Time Frame: 24 months ]
    Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery


Secondary Outcome Measures:
  • 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


Enrollment: 39
Study Start Date: October 2001
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Sham Comparator: Solution stem
The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for revision hip arthropathy

Exclusion Criteria:

  • Under 21 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253838


Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Ottawa Hospital Research Institute
Stryker Nordic
Investigators
Principal Investigator: Paul R Kim, MD, FRCSC OHRI
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00253838     History of Changes
Other Study ID Numbers: OHREB 2001215-01H
First Submitted: November 10, 2005
First Posted: November 15, 2005
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by Ottawa Hospital Research Institute:
revision hip arthroplasty
bone mineral density

Additional relevant MeSH terms:
Pharmaceutical Solutions
Cobalt
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs