AETOS Shoulder System for Shoulder Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of the AETOS Shoulder System, a new shoulder replacement device, to determine its safe use in the U.S. The study targets individuals needing a primary shoulder replacement due to conditions like rheumatoid arthritis, traumatic arthritis, or joint disease. Participants will receive the device in either an anatomic or reverse configuration, based on their condition. Ideal candidates have not had a shoulder replacement before, do not have uncontrolled diabetes, and do not smoke or heavily drink. As a Phase 3 trial, this study serves as the final step before FDA approval, allowing participants to contribute to the approval of a potentially groundbreaking treatment.
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. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the AETOS Shoulder System is safe for use?
Studies have shown that the AETOS Shoulder System, available in both reverse and anatomic versions, is designed to be safe and effective. The reverse version uses materials like titanium and a special coating to ensure durability and bone protection. This design is flexible to meet different needs while safeguarding the bone. Similarly, the anatomic version uses titanium and a strong metal called cobalt-chromium for stability.
The AETOS Shoulder System is currently undergoing safety testing in the USA. Although specific safety data from earlier studies isn't available, reaching this advanced stage of testing suggests it was well-tolerated in previous trials. This indicates it may be safe for individuals considering joining the study.12345Why are researchers excited about this trial?
The AETOS Shoulder System is unique because it offers two distinct configurations—Primary Reverse and Primary Anatomic—that cater to different patient needs. In contrast to standard shoulder replacement options, which typically focus on a single anatomical approach, the AETOS system provides flexibility in addressing various shoulder conditions. Researchers are excited about this treatment because it potentially allows for more personalized interventions, optimizing outcomes by tailoring the implant style to the patient's specific shoulder anatomy and functional requirements. This dual configuration could enhance recovery and improve shoulder mobility compared to traditional methods.
What evidence suggests that the AETOS Shoulder System is effective for shoulder treatment?
This trial will compare two configurations of the AETOS Shoulder System: the reverse configuration and the anatomic configuration. Research has shown that the AETOS Shoulder System holds promise for shoulder replacement surgeries. Studies on similar systems report that the reverse configuration yields good long-term results, with patients generally doing well after surgery. Another study found that the anatomic configuration worked well for 84% of patients over nearly 10 years, indicating its effectiveness and durability. Overall, evidence supports both configurations of the AETOS system as effective options for shoulder replacement.23467
Who Is on the Research Team?
Kolja Boese
Principal Investigator
Smith & Nephew, Inc.
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 arthroplasty using the AETOS Shoulder System in either anatomic or reverse configuration
Follow-up
Participants are monitored for implant survivorship and radiographic assessments
What Are the Treatments Tested in This Trial?
Interventions
- AETOS Shoulder System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Those subjects who have AETOS implanted in the Reverse configuration
Those subjects who have the AETOS implanted in the Primary Anatomic configuration
Find a Clinic Near You
Who Is Running the Clinical Trial?
Smith & Nephew, Inc.
Lead Sponsor
Dr. Maria Berkman
Smith & Nephew, Inc.
Chief Medical Officer since 2023
MD from Harvard Medical School
Dr. Deepak Nath
Smith & Nephew, Inc.
Chief Executive Officer since 2022
PhD in Theoretical Mechanics, University of California, Berkeley
Citations
AETOS Shoulder System - Clinical Trial Finder
Phase 2: Studies that gather preliminary data on effectiveness ... Those subjects who have the AETOS implanted in the Primary Anatomic configuration. : ...
Smith & Nephew, Inc. January 3, 2023 Cassidy Lemkau ...
The AETOS Shoulder System stem and head may be used by themselves for hemiarthroplasty. In a reverse configuration: A humeral stem (Titanium) ...
Outcomes of anatomic total shoulder arthroplasty
This study demonstrated an overall implant survival rate of 84% at a mean follow-up of nearly 10 years, confirming the durability of modern TSA ...
AETOS Shoulder System - ClinicalTrials.Veeva
This study will confirm the safety and performance of the AETOS Shoulder System in anatomic and reverse TSA. Revisions will not be enrolled into ...
Convertible-platform shoulder arthroplasty
This review aims to highlight the epidemiology, indications, and outcomes of convertible-platform total shoulder arthroplasty procedures.
June 7, 2023 Smith & Nephew, Inc. Patrick Hughes Senior ...
Device Description The AETOS Shoulder System consists of: In an anatomic configuration: A humeral stem (Titanium) with a plasma spray coating ( ...
7.
smith-nephew.com
smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/aetos-shoulder-systemAETOS shoulder system for TSA and RSA
AETOS Meta Stem TSA: Anatomic, 4-peg oval glenoid, designed to provide stability and resist the rocking horse,8,9 available in standard, 5˚ full wedge and 10˚ ...
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