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Completed

NCT Number: NCT00253838

A Comparison of Two Type of Stems in Revision Hip Arthroplasty

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.

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Key information

Conditions

Hip Arthroplasty

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidates for revision hip arthropathy

Exclusion criteria

  • Under 21 years of age

Treatment and study plan

Restoration HA stem

Procedure

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.

Other names: non applicable

Solution stem

Procedure

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

Other names: non applicable

Primary outcomes

  1. Safety of surgical implant

    Time frame: 24 months

    Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery

Secondary outcomes

  1. Patient outcome measures

    Time frame: pre-op, 6, 12, 24, 60 months

    Patient outcome measures will be assessed using the SF-12 and WOMAC questionnaires.

  2. Effectiveness of surgical implant

    Time frame: 24 months

    The Harris Hip Score will be used to evaluate the effectiveness of the surgical implant

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2010
Study completion
2012
First posted
Nov 15, 2005
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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