Artificial Shoulder Prosthesis for Shoulder Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of shoulder replacement devices from FX Shoulder Solutions for patients who have received them. Researchers seek information from individuals who have had these devices implanted since 2018 to assess performance and improvements in shoulder function. The trial is suitable for those who received an FX Shoulder Solutions replacement device from their doctor between January 1, 2018, and June 30, 2023. As a Phase 4 trial, the study focuses on understanding how the FDA-approved treatment benefits more patients, providing valuable insights into its long-term effectiveness.
Do I need to stop 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 shoulder replacement medical devices are safe?
Research has shown that shoulder replacement devices from FX Shoulder Solutions are generally safe. The parts used in these devices, such as the humeral stem and glenoid components, are designed for use with cement, a common and well-tested method. Studies indicate that the risk of infection with shoulder implants is relatively low, around 1.6% in some cases. Additionally, the FX V135 Shoulder Prosthesis system, another product from the same company, can be used for both full and partial shoulder replacements, demonstrating its versatility and safety. Testing has confirmed the device's effectiveness and safety, supporting the evidence that the products used in this trial are well-tolerated.12345
Why are researchers excited about this trial?
Researchers are excited about the shoulder replacement medical devices from FX Shoulder Solutions because they promise to advance the current standards in shoulder arthroplasty. Unlike traditional shoulder implants that may have limitations in range of motion or durability, these new devices aim to offer improved biomechanics and potentially longer-lasting performance. The unique design and materials used in these implants could lead to better joint function and quicker recovery times for patients, making them a significant step forward in shoulder replacement technology.
What evidence suggests that this shoulder replacement device is effective?
Research shows that shoulder replacement devices can greatly improve shoulder movement and reduce pain for people with severe shoulder arthritis. Studies have found that patients who receive shoulder replacements often experience a better range of motion and an improved quality of life. Data from similar devices indicate that most people experience significant pain relief and find daily activities easier. In this trial, participants will receive shoulder replacement devices manufactured by FX Shoulder Solutions. Devices from well-known companies, such as FX Shoulder Solutions, have successfully restored shoulder function. This evidence supports the potential effectiveness of FX Shoulder Solutions' devices in treating shoulder conditions requiring replacement.
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
Baseline Evaluation
Initial clinical evaluation and data collection following study enrollment
Postoperative Evaluations
Successive evaluations at specified postoperative intervals to monitor outcomes and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
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 and distributed by FX Shoulder Solutions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FX Shoulder Solutions
Lead Sponsor
Citations
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 ...
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.
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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