Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2014-03-31
2023-09-02
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Optivac and E1
Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE
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
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.
Sirius stem
A polished tapered stem
Optivac and Arcom
Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE
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
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
Sirius stem
A polished tapered stem
Optipac and E1
Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE
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
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.
Optipac and Arcom
Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE
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
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
Sirius stem
A polished tapered stem
Interventions
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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
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
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
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.
Sirius stem
A polished tapered stem
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed with primary Osteoarthritis
3. Patients who are fit for elective surgery (ASA I - III)
4. Patients with a BMI between 16 and 40
5. Patients who are skeletally mature
6. Patients aged over 18 at the time of surgery
7. Patients willing to return for follow-up evaluations
8. Patients who have the ability to follow instructions
9. Patients with sufficient bone stock and quality
Exclusion Criteria
2. Patients with diagnosed active infection
3. Patients with marked bone loss which could preclude or compromise adequate fixation of the device
4. Patients with Parkinson disease
5. Patients using immunosuppressive drugs
6. Patients with an immunosuppressive disease
7. Patients with BMI \<16
8. Patient with BMI \>40
9. Patients who are unfit for surgery (ASA IV - V)
10. Patients with acetabular or femoral osteotomy
11. Patients who had a THA on the contralateral side within last 6 months
12. Patients belonging to the vulnerable population: children, patients with mental
18 Years
85 Years
ALL
Yes
Sponsors
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Zimmer Biomet
INDUSTRY
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Gunnar Flivik, Md PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Orthopedics, Skane University Hospital, Lund University
Locations
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Deot of Orthopedics, Skane University Hospital, Lund University
Lund, , Sweden
Countries
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Other Identifiers
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Sirius RSA study_JT
Identifier Type: -
Identifier Source: org_study_id
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