OsteoarthritisNCT04063943
Long Term Sidus PMCF
A study testing Sidus Stem-Free Shoulder in people with Osteoarthritis and Post-traumatic; Arthrosis, run by Zimmer Biomet at 7 sites in 2 countries.
Trial summary
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Post-traumatic; Arthrosis
- What is being tested?
- Sidus Stem-Free Shoulder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Jul 2019to 31 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have previously participated in the Sidus IDE clinical trial.
- Patient must not have undergone revision of the Sidus shoulder.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
Who cannot join
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient did not previously participate in the Sidus IDE clinical trial.
- Patient no longer has Sidus shoulder implanted.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
MedStar Health
Baltimore, Maryland, 21218
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, 40241
Rothman Institute
Philadelphia, Pennsylvania, 19107
The Rothman Institute
Philadelphia, Pennsylvania, 19107
Canada3 sites
University of Calgary Sports Medicine Clinic
Calgary, Alberta, T2N 1N4
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Joseph's Health Care London - Hand and Upper Limb Centre
London, Ontario, N6A 4L6
About this study
Official title: Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
Read the detailed description
The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.
Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.
- Conditions
- Osteoarthritis, Post-traumatic; Arthrosis
- Being tested
- Sidus Stem-Free Shoulder
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidus Stem-Free ShoulderDevice
Device: Sidus Stem-Free Total Shoulder Arthroplasty System
| Study group | Role | What they receive |
|---|---|---|
| Sidus Stem-Free Total Shoulder | Experimental | This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System Receives: Device: Sidus Stem-Free Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Monitoring frequency of AE, SAE and UADEs.
Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Measured: 10 Years
Performance: ASES Scores
Will be determined by analyzing the ASES Questionnaire in subjects who received the Sidus Shoulder. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Measured: 10 Years
Implant Survival
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.
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 posted21 Aug 2019
- Study start12 Jul 2019
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Why it stopped: Sponsor has decided there is not a business need for this study and is not required to complete.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, RN MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063943
- Sponsor's protocol ID
- CSU2018-27E
- Status last verified
- May 2021
- First submitted
- 2 Jul 2019
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
- ClinicalTrials.gov ID
- NCT04063943
- Acronym / sponsor ID
- CSU2018-27E
- Conditions
- Osteoarthritis, Post-traumatic; Arthrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has decided there is not a business need for this study and is not required to complete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Aug 2019 (actual)
- 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 objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
Detailed description
The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.
Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sidus Stem-Free Total Shoulder | Experimental | Device: Sidus Stem-Free ShoulderThis arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have previously participated in the Sidus IDE clinical trial.
- Patient must not have undergone revision of the Sidus shoulder.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
Key exclusion criteria (5 listed)
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient did not previously participate in the Sidus IDE clinical trial.
- Patient no longer has Sidus shoulder implanted.
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 |
|---|---|---|
| Sidus Stem-Free ShoulderDevice: Sidus Stem-Free Total Shoulder Arthroplasty System | Device | Sidus Stem-Free Total Shoulder |
Primary outcome
Safety: Monitoring frequency of AE, SAE and UADEs.
Time frame: 10 Years
Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Performance: ASES Scores
Time frame: 10 Years
Will be determined by analyzing the ASES Questionnaire in subjects who received the Sidus Shoulder. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Implant Survival
Time frame: 10 Years
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
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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.
Kacy Arnold, RN MBA study director
Zimmer Biomet
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sidus Stem-Free Shoulder in people with Osteoarthritis and Post-traumatic; Arthrosis, run by Zimmer Biomet at 7 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety: Monitoring frequency of AE, SAE and UADEs. (time frame: 10 Years). The study lists 3 primary outcomes in all. 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 13 May 2021.