- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371382
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem (Sirius)
June 27, 2023 updated by: Zimmer Biomet
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vejle, Denmark, 7100
- Sygehus Vejle
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Wales
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Penarth, Wales, United Kingdom, CF64 2XX
- University Hospital of Wales, Llandough Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
minimum age: 18 maximum age: gender: both
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxford Hip score
Time Frame: 10 years
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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.
|
10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alun John, University Hospital of Wales
- Principal Investigator: Per Kjærsgaard-Andersen, MD, Lillebaelt Hospital Vejle, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
February 19, 2015
First Submitted That Met QC Criteria
February 19, 2015
First Posted (Estimated)
February 25, 2015
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ORTHO.CR.H41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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