NCT02307331

RSA Study of Sirius Stem and Exceed Cup

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Optivac	A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results
DEVICE	Optipac	A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system
DEVICE	Arcom (Exceed cup)	The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene
DEVICE	E1 (Exceed cup)	The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.
DEVICE	Sirius stem	A polished tapered stem

Timeline

• Start date: 2014-03-01
• Primary completion: 2020-08-01
• Completion: 2023-09-02
• First posted: 2014-12-04
• Last updated: 2023-09-06

Locations

1 site across 1 country: Sweden