Shoulder OsteoarthritisNCT02452957
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
An observational study of Shoulder Osteoarthritis, run by Stryker Trauma and Extremities at 1 site in Germany.
Trial summary
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2020to Jan 2022
- 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: Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.
Who may be able to join
- A subject must meet all of the following inclusion criteria in order to enter the study:
- Adult subject 18 years or older,
- Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
- Scapula and proximal humerus must have reached skeletal maturity,
- Willing and able to comply with the protocol,
- Willing and able to personally sign the informed consent form,
- Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.
Who cannot join
- A subject will not be eligible to participate in the study if any of the following conditions is present:
- lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
- Severe Walch grade B2 glenoid defined as >60% posterior head displacement and >20% posterior glenoid bone loss,
- metal allergies or sensitivity,
- infection at or near the site of implantation,
- distant or systemic infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
- Conditions
- Shoulder Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Device: Simpliciti™ System | The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation. The Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with device related adverse events as a measure of safety
All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.
Measured: 24 months
Secondary outcomes (4)
Change in the Range of Motions (ROM) as a measure of effectiveness
Changes in ROM variables from the pre-implant visit to each follow-up visit will be calculated and sumarized until 24-month visit.
Measured: 24 months
Change in the Constant Score as a measure of effectiveness
Changes in the Constant Score from the pre-implant visit to each follow-up visits will be calculated and summarized until 24-month visit.
Measured: 24 months
Change in the DASH Score as a measure of improvement in the patients' Quality of Life
Changes in the DASH Score from the pre-implant visit to each follow-up visits will be calculated and summarised until 24-month visit.
Measured: 24 months
Change in humeral cortical thickness as an evaluation of Stress Shielding
Changes in humeral cortical thickness from the pre-implant to 24-month visit will be mesured according to the modified method of Tingart \& Al.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Contract issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve A. Erickson, Study director, Stryker Trauma and ExtremitiesUlrich Brunner, MD, Prof., Principal investigator, Krankenhaus Agatharied
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452957
- Sponsor's protocol ID
- 1206-T-SIMPLICITI-RM
- Status last verified
- Mar 2017
- First submitted
- 16 May 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02452957
- Acronym / sponsor ID
- 1206-T-SIMPLICITI-RM
- Conditions
- Shoulder Osteoarthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Contract issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 25 May 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 aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Simpliciti™ System | – | –The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation. The Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.
Key inclusion criteria (7 listed)
- A subject must meet all of the following inclusion criteria in order to enter the study:
Key exclusion criteria (6 listed)
- A subject will not be eligible to participate in the study if any of the following conditions is present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with device related adverse events as a measure of safety
Time frame: 24 months
All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.
4 secondary outcomes
Change in the Range of Motions (ROM) as a measure of effectiveness
Time frame: 24 months
Change in the Constant Score as a measure of effectiveness
Time frame: 24 months
Change in the DASH Score as a measure of improvement in the patients' Quality of Life
Time frame: 24 months
Change in humeral cortical thickness as an evaluation of Stress Shielding
Time frame: 24 months
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 Oct 2017.
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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.
Steve A. Erickson study director
Stryker Trauma and Extremities
Ulrich Brunner, MD, Prof. principal investigator
Krankenhaus Agatharied
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Osteoarthritis, run by Stryker Trauma and Extremities at 1 site in Germany.
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 7 inclusion and 6 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 Oct 2017. 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 Germany. 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?
Number of patients with device related adverse events as a measure of safety (time frame: 24 months). 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 Oct 2017.