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
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2023
CompletedSeptember 6, 2023
September 1, 2023
6.4 years
November 25, 2014
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Conventional Radiography (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)
Preoperatively, 1 year, 2 years and 5 years
EQ5D
Preoperatively, 1 year, 2 years and 5 years
Study Arms (4)
Optivac and E1
OTHERSirius stem used with Optivac mixed cement - Exceed Cup - E1 PE
Optivac and Arcom
OTHERSirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE
Optipac and E1
OTHERSirius stem used with Optipac mixed cement - Exceed Cup - E1 PE
Optipac and Arcom
OTHERSirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Zimmer Biometcollaborator
Study Sites (1)
Deot of Orthopedics, Skane University Hospital, Lund University
Lund, 221 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunnar Flivik, Md PhD
Dept of Orthopedics, Skane University Hospital, Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2014
First Posted
December 4, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2020
Study Completion
September 2, 2023
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share