OsteoarthritisPRNCT02680340
POLARSTEM Retrospective Multicenter Study
An observational study of Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 5 sites in France.
Trial summary
The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years. The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 502 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2016to Dec 2016
- 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: 502 male and female subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years.
Who may be able to join
- Subject required and received primary total hip arthroplasty between 2002 and 2005.
- Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
- Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
- Subject was aged between 18 and 75 at time of surgery.
- Signed Informed Consent (ICF).
Who cannot join
- Subject received the cemented POLARSTEM™.
- Previously failed endoprosthesis and/or THR components in relevant hip.
- Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique la Parisière
Bourg-de-Péage, 26300
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
Centre Hospitalier du Forez- Montbrison
Montbrison, 42605
Centre Hospitalier de Montélimar
Montélimar, 26200
Clinique du Renaison
Roanne, 42300
About this study
Official title: Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study
The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.
The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance
Read the detailed description
This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.
- Conditions
- Osteoarthritis
- Being tested
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty THA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Also called Polarstem primary THA
Patients who had a primary THA between 2002 and 2005
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral stem revision rate at 10 years for any reason
Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects
Measured: since surgery until 10 years Follow Up
Secondary outcomes (5)
Number of subjects with revision of any components for any reason
Long-term cumulative revision rate of the cup will be evaluated in 502 subjects
Measured: date of surgery until 10 years Follow Up
Standard radiographic assessment at least at 10 years
radiographic evaluation on x-rays to assess the osseointegration and orientation of cup and stem, heterotopic ossification, signs of radiolucent lines, osteolysis, atrophy and hypertrophy
Measured: date of surgery and at 10 years Follow Up
Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO
Measured: at 10 years Follow Up
Merle D'Aubigné and Postel (MAP) at least at 10-year assessment
Measured: pre-operative and at 10 years Follow Up
Adverse Events
Measured: through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionDec 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnaud Fiquet, Dr. med., Principal investigator, Infirmerie Protestante de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680340
- Sponsor's protocol ID
- 14-4562-05
- Acronym
- PR
- Status last verified
- Feb 2017
- First submitted
- 5 Jan 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study
- ClinicalTrials.gov ID
- NCT02680340
- Acronym / sponsor ID
- PR / 14-4562-05
- Conditions
- Osteoarthritis
- Keywords
- Total Hip Arthroplasty THA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Feb 2016 (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 primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.
The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance
Detailed description
This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 502 male and female subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years.
Key inclusion criteria (5 listed)
- Subject required and received primary total hip arthroplasty between 2002 and 2005.
- Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
- Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
- Subject was aged between 18 and 75 at time of surgery.
- Signed Informed Consent (ICF).
Key exclusion criteria (3 listed)
- Subject received the cemented POLARSTEM™.
- Previously failed endoprosthesis and/or THR components in relevant hip.
- Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.
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 |
|---|---|---|
| Total Hip ArthroplastyAlso: Polarstem primary THAPatients who had a primary THA between 2002 and 2005 | Procedure or surgery | – |
Primary outcome
Femoral stem revision rate at 10 years for any reason
Time frame: since surgery until 10 years Follow Up
Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects
5 secondary outcomes
Number of subjects with revision of any components for any reason
Time frame: date of surgery until 10 years Follow Up
Standard radiographic assessment at least at 10 years
Time frame: date of surgery and at 10 years Follow Up
Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO
Time frame: at 10 years Follow Up
Merle D'Aubigné and Postel (MAP) at least at 10-year assessment
Time frame: pre-operative and at 10 years Follow Up
Adverse Events
Time frame: through study completion, an average of 10 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 23 Feb 2017.
- 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.
Arnaud Fiquet, Dr. med. principal investigator
Infirmerie Protestante de Lyon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Smith & Nephew Orthopaedics AG at 5 sites in France.
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 5 inclusion and 3 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Femoral stem revision rate at 10 years for any reason (time frame: since surgery until 10 years Follow Up). 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 23 Feb 2017.