A Comparison of Two Type of Stems in Revision Hip Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Arthroplasty

Intervention / Treatment
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* Procedure: Restoration HA stem
* Procedure: Solution stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for revision hip arthropathy Exclusion Criteria: Under 21 years of age

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restoration HA Stem<br>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<br>* 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.<br>* Other names: non applicable;|
| Sham Comparator: Solution stem<br>The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating. | Procedure: Solution stem<br>* The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of surgical implant | Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery | 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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revision hip arthroplasty, bone mineral density