OsteoarthritisNCT02307331
RSA Study of Sirius Stem and Exceed Cup
A study testing Optivac, Optipac and Arcom (Exceed cup) in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Optivac, Optipac and Arcom (Exceed cup)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to 2 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Patients willing to return for follow-up evaluations
- Patients who have the ability to follow instructions
- Patients with sufficient bone stock and quality
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Deot of Orthopedics, Skane University Hospital, Lund University
Lund, 221 85
About this study
Official title: 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
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.
Read the detailed description
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
- Conditions
- Osteoarthritis
- Being tested
- Optivac, Optipac, Arcom (Exceed cup), E1 (Exceed cup), Sirius stem
- Keywords
- Total Hip Replacement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptivacDevice
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
OptipacDevice
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 stemDevice
A polished tapered stem
| Study group | Role | What they receive |
|---|---|---|
| Optivac and E1 | Other | Sirius stem used with Optivac mixed cement - Exceed Cup - E1 PE Receives: Device: Optivac; Device: E1 (Exceed cup); Device: Sirius stem |
| Optivac and Arcom | Other | Sirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE Receives: Device: Optivac; Device: Arcom (Exceed cup); Device: Sirius stem |
| Optipac and E1 | Other | Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE Receives: Device: Optipac; Device: E1 (Exceed cup) |
| Optipac and Arcom | Other | Sirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE Receives: Device: Optipac; Device: Arcom (Exceed cup); Device: Sirius stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Signs of radiolucent lines or obvious change of position will be measured in mm
Measured: First postoperative day, 2 years and 5 years
HOOS (Hip specific health questionnaire)
Hip specific health questionnaire - HOOS
Measured: Preoperatively, 1 year, 2 years and 5 years
EQ5D
General health questionnaire - EQ-5D
Measured: Preoperatively, 1 year, 2 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2020
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Gunnar Flivik, Md PhD, Principal investigator, Dept of Orthopedics, Skane University Hospital, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307331
- Sponsor's protocol ID
- Sirius RSA study_JT
- Status last verified
- Sep 2023
- First submitted
- 25 Nov 2014
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02307331
- Acronym / sponsor ID
- Sirius RSA study_JT
- Conditions
- Osteoarthritis
- Keywords
- Total Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Optivac and E1 | Other | Device: Optivac, Device: E1 (Exceed cup), Device: Sirius stemSirius stem used with Optivac mixed cement - Exceed Cup - E1 PE |
| Optivac and Arcom | Other | Device: Optivac, Device: Arcom (Exceed cup), Device: Sirius stemSirius stem used with Optivac mixed cement - Exceed Cup - Arcom PE |
| Optipac and E1 | Other | Device: Optipac, Device: E1 (Exceed cup)Sirius stem used with Optipac mixed cement - Exceed Cup - E1 PE |
| Optipac and Arcom | Other | Device: Optipac, Device: Arcom (Exceed cup), Device: Sirius stemSirius stem used with Optipac mixed cement - Exceed Cup - Arcom PE |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptivacA 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 | Device | Optivac and Arcom, Optivac and E1 |
| OptipacA 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 | Device | Optipac and Arcom, Optipac and E1 |
| 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 | Device | Optipac and Arcom, Optivac and Arcom |
| 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. | Device | Optipac and E1, Optivac and E1 |
| Sirius stemA polished tapered stem | Device | Optipac and Arcom, Optivac and Arcom, Optivac and E1 |
Primary outcome
Radiostereometry (RSA) - change in migration and wear over time
Time frame: First postoperative day, 3 months, 1 year, 2 years and 5 years
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.
3 secondary outcomes
Conventional Radiography (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)
Time frame: Preoperatively, 1 year, 2 years and 5 years
EQ5D
Time frame: Preoperatively, 1 year, 2 years and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Flivik, Md PhD principal investigator
Dept of Orthopedics, Skane University Hospital, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optivac, Optipac and Arcom (Exceed cup) in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiostereometry (RSA) - change in migration and wear over time (time frame: First postoperative day, 3 months, 1 year, 2 years and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.