RSA Study of Sirius Stem and Exceed Cup

Study Overview
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Brief Summary
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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
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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: Demonstrate a comparable migration pattern as is described in published literature on other double tapered polished cemented stems 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

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Optivac
* Device: Optipac
* Device: Arcom (Exceed cup)
* Device: E1 (Exceed cup)
* Device: Sirius stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are eligible for cemented total hip arthroplasty Patients diagnosed with primary Osteoarthritis Patients who are fit for elective surgery (ASA I - III) Patients with a BMI between 16 and 40 Patients who are skeletally mature Patients aged over 18 at the time of surgery Patients willing to return for follow-up evaluations Patients who have the ability to follow instructions Patients with sufficient bone stock and quality Exclusion Criteria: Female patients who are pregnant or planning pregnancy during the course of the study (no use of adequate birth control) Patients with diagnosed active infection Patients with marked bone loss which could preclude or compromise adequate fixation of the device Patients with Parkinson disease Patients using immunosuppressive drugs Patients with an immunosuppressive disease Patients with BMI <16 Patient with BMI >40 Patients who are unfit for surgery (ASA IV - V) Patients with acetabular or femoral osteotomy Patients who had a THA on the contralateral side within last 6 months Patients belonging to the vulnerable population: children, patients with mental

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optivac and E1<br>Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE | Device: Optivac<br>* 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<br>Device: E1 (Exceed cup)<br>* 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.<br>Device: Sirius stem<br>* A polished tapered stem<br>|
| Other: Optivac and Arcom<br>Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE | Device: Optivac<br>* 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<br>Device: Arcom (Exceed cup)<br>* 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<br>Device: Sirius stem<br>* A polished tapered stem<br>|
| Other: Optipac and E1<br>Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE | Device: Optipac<br>* 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<br>Device: E1 (Exceed cup)<br>* 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.<br>|
| Other: Optipac and Arcom<br>Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE | Device: Optipac<br>* 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<br>Device: Arcom (Exceed cup)<br>* 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<br>Device: Sirius stem<br>* A polished tapered stem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | First postoperative day, 3 months, 1 year, 2 years and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | First postoperative day, 2 years and 5 years | 
| HOOS (Hip specific health questionnaire) | Hip specific health questionnaire - HOOS | Preoperatively, 1 year, 2 years and 5 years | 
| EQ5D | General health questionnaire - EQ-5D | Preoperatively, 1 year, 2 years and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Replacement