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RSA Study of Sirius Stem and Exceed Cup

Osteoarthritis Clinical Trial

Official title:
RCT of the Sirius Stem Used in Conjunction With the Exceed ABT Cemented Cup and OptiPac/OptiVac Cement - Model Based RSA, Clinical and Radiographic Outcomes

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.

Clinical Trial Description

This is a comparative, prospective randomized Radiostereometry (RSA) study, lead on 48 patients in a single site. All 48 patients will be pooled in a single group for the evaluation of the primary criterion for evaluation, but randomized into four groups for the evaluation of the secondary criteria for evaluation The objectives of the study are to: 1. Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems 2. Measure wear pattern in the cup made of vitamin-E doped polyethylene or conventional Arcom polyethylene 2)Demonstrate non-inferiority of Optipac vs. Optivac cement mixing systems on the stem side 3)Evaluate the clinical outcome and survivorship of the implant ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02307331
Study type Interventional
Source Region Skane
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date September 2, 2023
View Details
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