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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optivac and E1 | Other | Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE |
|
| Optivac and Arcom | Other | Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE |
|
| Optipac and E1 | Other | Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE |
|
| Optipac and Arcom | Other | Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optivac | Device | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Flivik, Md PhD | Dept of Orthopedics, Skane University Hospital, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deot of Orthopedics, Skane University Hospital, Lund University | Lund | 221 85 | Sweden |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Optipac | Device | 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 |
|
| Arcom (Exceed cup) | Device | 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 |
|
| E1 (Exceed cup) | Device | 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. |
|
| Sirius stem | Device | A polished tapered stem |
|
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 |