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A Comparison of Two Type of Stems in Revision Hip Arthroplasty

This study is ongoing, but not recruiting participants.
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
History of Changes
  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 Phase
Hip Arthroplasty
 Procedure: BMD
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • bone mineral density scores [ Time Frame: pre-op, 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2001
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Restoration Stem
Restoration Stem
 Procedure: BMD
bone mineral density
Other Name: non applicable
Active Comparator: Solution stem
Solution stem
 Procedure: BMD
bone mineral density
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for revision hip arthropathy

Exclusion Criteria:

  • Under 21 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00253838     History of Changes
Other Study ID Numbers: OHREB 2001215-01H
Study First Received: November 10, 2005
Last Updated: October 24, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 19, 2013