A Comparison of Two Type of Stems in Revision Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Arthroplasty
• Interventions: Procedure: Solution stem; Procedure: Restoration HA stem

• Registration Number: NCT00253838
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

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.

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Primary Completion: 2010-09
• Study Completion: 2012-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Candidates for revision hip arthropathy

Exclusion Criteria

• Under 21 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solution stem	Solution stem	The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
Restoration HA Stem	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

Primary Outcome Measures

Name	Time	Method
Safety of surgical implant	24 months	Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery

Secondary Outcome Measures

Name	Time	Method
Effectiveness of surgical implant	24 months	The Harris Hip Score will be used to evaluate the effectiveness of the surgical implant
Patient outcome measures	pre-op, 6, 12, 24, 60 months	Patient outcome measures will be assessed using the SF-12 and WOMAC questionnaires.

Trial Locations

Locations (1)

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada