Actively Recruiting
AETOS Shoulder System Post Market Clinical Investigation
Led by Smith & Nephew, Inc. · Updated on 2024-05-07
220
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the AETOS Shoulder System for use in the United States. This study is an observational, prospective, open, adaptive, multi-center investigation enrolling up to 220 participants undergoing primary anatomic or reverse total shoulder arthroplasty (TSA) due to shoulder osteoarthritis or arthritis. The study excludes patients who have had revision surgeries and does not include a comparator group or randomization. Participants will receive the AETOS Shoulder System implant in either an anatomic or reverse configuration during elective shoulder replacement surgery. The device has been cleared for market use and is provided through normal commercial channels. The humeral stems are designed with fins and a porous plasma coating to support fixation within the proximal humerus. Two groups are studied: those receiving the anatomic implant and those receiving the reverse implant. Throughout the study, participants will attend follow-up visits at 6 months, 1 year, 2 years, 3.5 years, and 5 years to assess implant survivorship and perform radiographic evaluations including bone remodeling, component positioning, and implant condition. Functional assessments such as the American Shoulder and Elbow Score, Constant Murley Score, Simple Shoulder Test, and Single Assessment Numeric Evaluation will be collected. The study aims to monitor long-term implant performance and patient outcomes over several years.
CONDITIONS
Brief Title
AETOS Shoulder System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old and skeletally mature.
- Undergoing primary elective anatomic or reverse shoulder replacement surgery for rheumatoid arthritis, traumatic arthritis, non-inflammatory degenerative joint disease, or correction of functional deformity.
- Willing and able to attend all study-related procedures and follow-up visits.
- Geographically stable and able to return to the study site for follow-up.
- Informed of study risks and willing to provide consent for participation.
You will not qualify if you...
- Contraindication to the AETOS Shoulder System.
- Undergoing revision shoulder replacement surgery.
- Indicated for hemiarthroplasty.
- Traumatic injury or fracture.
- Uncontrolled diabetes with hemoglobin A1C 7.5 or greater.
- Conditions preventing proper healing or implant fixation.
- Poor bone quality or insufficient bone stock.
- Rapid joint destruction or severe osteoporosis.
- Osteomalacia.
- Muscular, neurologic, or vascular deficiencies affecting surgery outcome.
- Known allergies to implant materials.
- Active or systemic infection, sepsis, or osteomyelitis.
- Abnormal blood test results indicating infection.
- Non-functional deltoid or rotator muscles for reverse arthroplasty.
- Significant upper brachial plexus injury or axillary nerve paralysis for reverse arthroplasty.
- Uncooperative or vulnerable subjects unable to consent.
- Pregnancy or plans to become pregnant during follow-up.
- BMI over 35 kg/m2 or other factors compromising surgery outcome.
- High-risk activities or likelihood of falls.
- Smoking, vaping, alcohol, or drug abuse within 180 days.
- Previous participation in this trial or concurrent participation in other trials.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (surgery day)
Participants have the AETOS Shoulder System implanted in either anatomic or reverse configuration as part of their shoulder replacement surgery.
1 visit (in-person) for the implantation procedure
Duration - Up to 5 years
Participants are followed up to assess implant survivorship, radiographic outcomes, and shoulder function over time.
Visits at 6 months, 1 year, 2 years, 3.5 years, and 5 years post-implantation
Trial Site Locations
Total: 5 locations
1
California Pacific Orthopedics
San Francisco, California, United States, 94118
Actively Recruiting
2
Western Orthopaedics
Denver, Colorado, United States, 80210
Actively Recruiting
3
Hughston Foundation
Columbus, Georgia, United States, 31909
Actively Recruiting
4
Center for Orthopedics and Neurosurgical Care
Bend, Oregon, United States, 97701
Actively Recruiting
5
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
T
Tammy Clark, MPH
K
Karlie Morgan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here