No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
Stryker Trauma and Extremities · Industry
Who this trial is looking for
This trial is looking for adults with specific shoulder conditions who are considering shoulder surgery. Participants will help gather information about the safety and effectiveness of a particular device used in surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I can sign an informed consent form.
I am willing to follow the study guidelines.
I am a candidate for shoulder surgery with the study device.
I meet the local regulatory requirements.
You may not be able to join if
I am unable to follow the study procedures.
I am part of a vulnerable group that needs a representative.
I have an active infection or serious illness.
I have poor bone quality that may lead to surgery problems.
I have significant nerve damage in my arm.
I have inadequate bone support for the surgery.
I have a neuromuscular disease.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewe…
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.
Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 18 years or older at the time of the informed consent or non-opposition (when applicable).
* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
* Willing and able to comply with the requirements of the study protocol.
* Considered a …
Inclusion Criteria:
* 18 years or older at the time of the informed consent or non-opposition (when applicable).
* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
* Willing and able to comply with the requirements of the study protocol.
* Considered a candidate for shoulder arthroplasty using a study device.
* Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
Exclusion Criteria:
* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
* Active local or systemic infection, sepsis, or osteomyelitis
* Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
* Significant injury to the brachial plexus
* Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
* Neuromuscular disease (e.g., joint neuropathy)
* Patient with known allergy to one of the product materials
* Metabolic disorders which may impair bone formation
* Patient pregnancy
* Planned for two-stage surgery
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