Arthroplasty, Replacement, HipSiriusNCT02371382
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem
An observational study of Arthroplasty, Replacement, Hip, run by Zimmer Biomet at 2 sites in 2 countries.
Trial summary
The purpose of this multicentre, prospective study is: Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years. Report Safety and Survivorship up to 10 years F/up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Arthroplasty hip
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2013to Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: minimum age: 18 maximum age: gender: both
Who may be able to join
- Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties
Who cannot join
- Absolute contraindications include:
- infection, sepsis, osteomyelitis
- Additional contraindications include:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- Metabolic disorders which may impair bone formation
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- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
University Hospital of Wales, Llandough Hospital
Penarth, Wales, CF64 2XX
About this study
The purpose of this multicentre, prospective study is:
- Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
- Report Safety and Survivorship up to 10 years F/up.
Read the detailed description
This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Arthroplasty hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroplasty hipDevice
Hip replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Change in Harris Hip Score from Baseline to 1 Year post-surgery, Harris Hip Score, 0-100 points. The higher the positive difference between baseline and follow up the better the result
Measured: 1 year
Secondary outcomes (1)
Oxford Hip score
Oxford Hip Score at 1,3,5, 7 and 10 year postop, Oxford Hip score 0-48 points, The higher the positive difference the better the result.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startMar 2013
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alun John, Principal investigator, University Hospital of WalesPer Kjærsgaard-Andersen, MD, Principal investigator, Lillebaelt Hospital Vejle, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371382
- Sponsor's protocol ID
- ORTHO.CR.H41
- Acronym
- Sirius
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2015
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem
- ClinicalTrials.gov ID
- NCT02371382
- Acronym / sponsor ID
- Sirius / ORTHO.CR.H41
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Feb 2015 (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 multicentre, prospective study is:
- Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
- Report Safety and Survivorship up to 10 years F/up.
Detailed description
This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- minimum age: 18 maximum age: gender: both
Key inclusion criteria (6 listed)
- Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Key exclusion criteria (10 listed)
- Absolute contraindications include:
- infection, sepsis, osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- Osteoporosis,
- Metabolic disorders which may impair bone formation
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 |
|---|---|---|
| Arthroplasty hipHip replacement | Device | – |
Primary outcome
Harris Hip Score
Time frame: 1 year
Change in Harris Hip Score from Baseline to 1 Year post-surgery, Harris Hip Score, 0-100 points. The higher the positive difference between baseline and follow up the better the result
1 secondary outcome
Oxford Hip score
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
Alun John principal investigator
University Hospital of Wales
Per Kjærsgaard-Andersen, MD principal investigator
Lillebaelt Hospital Vejle, Denmark
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip, run by Zimmer Biomet at 2 sites in 2 countries.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, United Kingdom. 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?
Results are not available in the source record.
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?
Harris Hip Score (time frame: 1 year). 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 1 Jul 2024.