A Comparison of Two Type of Stems in Revision Hip Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00253838
First received: November 10, 2005
Last updated: October 24, 2011
Last verified: October 2011

November 10, 2005
October 24, 2011
October 2001
December 2011   (final data collection date for primary outcome measure)
bone mineral density scores [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]
bone mineral density scores
Complete list of historical versions of study NCT00253838 on ClinicalTrials.gov Archive Site
Rates of osteolysis/radiolucent lines on radiographs WOMAC SF-12 Harris Hip Score Rate of revision Rate of complication [ Time Frame: pre-op, 6, 12, 24, 60 months ] [ Designated as safety issue: No ]
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
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hip Arthroplasty
Procedure: BMD
bone mineral density
Other Name: non applicable
  • Active Comparator: Restoration Stem
    Restoration Stem
    Intervention: Procedure: BMD
  • Active Comparator: Solution stem
    Solution stem
    Intervention: Procedure: BMD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidates for revision hip arthropathy

Exclusion Criteria:

  • Under 21 years of age
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00253838
OHREB 2001215-01H
No
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Stryker Nordic
Principal Investigator: Paul R Kim, MD, FRCSC OHRI
Ottawa Hospital Research Institute
October 2011

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