A Comparison of Two Type of Stems in Revision Hip Arthroplasty

Hip Arthroplasty Clinical Trial

Official title:

A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253838
• Other study ID #: OHREB 2001215-01H
• Status: Completed
• Phase: N/A
• First received: November 10, 2005
• Last updated: September 20, 2017
• Start date: October 2001
• Est. completion date: March 2012

Study information

• Verified date: September 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Candidates for revision hip arthropathy

Exclusion Criteria:

• Under 21 years of age

Related Conditions & MeSH terms

• Hip Arthroplasty

Intervention

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.
• Solution stem
The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Stryker Nordic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of surgical implant	Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery	24 months
Secondary	Patient outcome measures	Patient outcome measures will be assessed using the SF-12 and WOMAC questionnaires.	pre-op, 6, 12, 24, 60 months
Secondary	Effectiveness of surgical implant	The Harris Hip Score will be used to evaluate the effectiveness of the surgical implant	24 months