Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis
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|ClinicalTrials.gov Identifier: NCT01668160|
Recruitment Status : Withdrawn
First Posted : August 17, 2012
Last Update Posted : November 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Hip Failure of Primary THA||Procedure: Bead placement during revision hip replacement surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Revision Total Hip
patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.
Procedure: Bead placement during revision hip replacement surgery
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components
- Stability of Acetabular and femoral components [ Time Frame: 1, 2, 3, 5 years after surgery ]RSA films will be taken at the prescribed time intervals to measure component mothion over time.
- Wear of the polyethlene component [ Time Frame: 1, 2, 3, 5 years after surgery ]The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.
- Assessment/questionaire HOOS [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]Hip disability and Osteoarthritis Outcome Score
- Assessment/Questionaires Harris Hip Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]Hip specific questionaire
- Assessment/Questionaire UCLA Activity Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]Measure of activity level
- Assessment/Questionaire EQ-5D [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]General health and cost effectiveness measure
- Assessment/Questionaire Case Mix indicator [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]Determines comorbidities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668160
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|