FX Artificial Shoulder Prosthesis for Shoulder Fracture
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on studying shoulder replacement devices made by FX Shoulder Solutions. The goal is to gather information on the effectiveness and safety of these devices for patients. The trial seeks individuals who have undergone shoulder replacement surgery with an FX device. Those who have had this type of surgery might be suitable candidates for the trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that these implanted devices are safe?
A previous study found that shoulder replacement devices from FX Shoulder Solutions are generally safe for patients. Research shows a low chance of serious infection, a possible side effect, at about 1.6%. These devices have received approval for sale in the USA, indicating they have passed specific safety checks, which can reassure patients about their safety. Studies have also examined patient outcomes after receiving these devices, demonstrating their effectiveness and durability. While these results suggest the devices are well-tolerated, discussing potential risks with a doctor before joining a trial is always important.12345
Why are researchers excited about this trial?
FX Shoulder Solutions' shoulder replacement devices are exciting because they aim to improve the fit and function of shoulder implants. Unlike traditional shoulder replacements, which may not always perfectly match a patient's anatomy, these devices are designed to better accommodate the unique shapes and sizes of different shoulders. This tailored approach could potentially lead to better movement and less discomfort for patients after surgery. Researchers are hopeful that these advancements will provide a more natural feel and longer-lasting results compared to existing options.
What evidence suggests that these shoulder replacement devices are effective?
Research has shown that shoulder replacement devices from FX Shoulder Solutions hold promise for individuals with shoulder issues. One study on stemless shoulder replacement for arthritis found good results both clinically and in X-rays. This less invasive method preserves more bone, potentially speeding up recovery. Additionally, these devices are designed to align better with the body's natural shape, enhancing shoulder movement. Overall, these features make the shoulder replacement devices effective for treating conditions like arthritis.26789
Who Is on the Research Team?
Brian Rogers, BS
Principal Investigator
FX Shoulder Solutions
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo shoulder replacement surgery with FX Shoulder Solutions medical devices
Follow-up
Participants are monitored for safety, effectiveness, and survivorship of the implant
What Are the Treatments Tested in This Trial?
Interventions
- FX Artificial Shoulder Prosthesis
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions
Find a Clinic Near You
Who Is Running the Clinical Trial?
FX Shoulder Solutions
Lead Sponsor
Citations
Stemless shoulder arthroplasty: what are the benefits?
Stemless implants exhibit biomechanical advantages, adaptability to patient anatomy, bone preservation, simplified surgical techniques, and less invasive ...
Study Details | NCT06077942 | FX Shoulder Solutions ...
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices. To demonstrate effectiveness, safety and survivorship.
Short term results of anatomic stemless shoulder replacement ...
The aim of this study was to analyze clinical and radiological results of this stemless TSA implanted for osteoarthritis (OA). Methods. A retrospective study of ...
Post Market Clinical Follow-up Study for Arthroplasty ...
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect ...
FX Shoulder USA, Inc. February 16, 2021 Kathy Trier VP ...
Patient outcomes were compared to the performance goal based upon the primary predicate device clinical trial. The percentage of subjects ...
FX Shoulder USA, Inc. July 16, 2020 Kathy Trier VP ...
The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only. TiN coated Heads are not ...
Cementless and locked prosthesis for the treatment of 3- ...
The published rate of deep infection after HA for fracture is 1.6% [25]. For all aetiologies combined, the prevalence of infection of anatomical shoulder ...
FX Shoulder USA, Inc. June 7, 2022 Kathy Trier VP ...
The FX V135 Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an ...
FX Shoulder Solutions Retrospective / Prospective Clinical ...
To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices. To demonstrate effectiveness, safety and survivorship.
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