A Comparison of Two Type of Stems in Revision Hip Arthroplasty
A Randomized Controlled Trial Comparing a Titanium to a Cobalt Chrome Femoral Stem in Revision Hip Arthroplasty: A Pilot Study
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 25, 2017
September 1, 2017
8.9 years
November 10, 2005
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of surgical implant
Safety of surgical implant will be assessed by reviewing revision rates and complication rates post surgery
24 months
Secondary Outcomes (2)
Patient outcome measures
pre-op, 6, 12, 24, 60 months
Effectiveness of surgical implant
24 months
Study Arms (2)
Restoration HA Stem
ACTIVE COMPARATORThe 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
Solution stem
SHAM COMPARATORThe Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
Interventions
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.
The Solution stem is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating.
Eligibility Criteria
You may qualify if:
- Candidates for revision hip arthropathy
You may not qualify if:
- Under 21 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Stryker Nordiccollaborator
Study Sites (1)
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R Kim, MD, FRCSC
OHRI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
October 1, 2001
Primary Completion
September 1, 2010
Study Completion
March 1, 2012
Last Updated
September 25, 2017
Record last verified: 2017-09