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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
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
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
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
Deot of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden
Radiostereometry (RSA) - change in migration and wear over time
Prosthesis migration and cup wear are measured over time, from baseline directly postop up to 5years. Measures are given in change in mm (translation) and degrees (rotation) around x, y and z-axis.
Time frame: First postoperative day, 3 months, 1 year, 2 years and 5 years
Conventional Radiography (Signs of radiolucent lines or obvious change of position will be measured in mm)
Signs of radiolucent lines or obvious change of position will be measured in mm
Time frame: First postoperative day, 2 years and 5 years
HOOS (Hip specific health questionnaire)
Hip specific health questionnaire - HOOS
Time frame: Preoperatively, 1 year, 2 years and 5 years
EQ5D
General health questionnaire - EQ-5D
Time frame: Preoperatively, 1 year, 2 years and 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
A polished tapered stem