Actively Recruiting
AETOS Shoulder System
Led by Smith & Nephew, Inc. · Updated on 2024-05-07
220
Participants Needed
5
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization
CONDITIONS
Official Title
AETOS Shoulder System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 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 complete all study procedures, visits, and post-operative therapy
- Geographically stable and able to return for all follow-up visits
- Informed of study risks and requirements and able to provide consent
You will not qualify if you...
- Contraindication to AETOS device
- Undergoing revision shoulder replacement surgery
- Indicated for hemiarthroplasty
- Traumatic injury or fracture
- Uncontrolled diabetes with hemoglobin A1C of 7.5 or greater
- Conditions preventing proper healing or implant fixation
- Poor bone quality or insufficient bone stock
- Rapid joint destruction, marked bone loss, or osteomalacia
- Muscular, neurologic, or vascular deficiencies affecting outcomes
- Allergies to implant materials
- Active infection, sepsis, or osteomyelitis
- Abnormal blood test results unexplained by other disease
- Non-functional deltoid or external rotator muscles for reverse arthroplasty
- Significant injury to brachial plexus or axillary nerve paralysis for reverse arthroplasty
- Uncooperative or neurologic disorder preventing study participation
- Pregnant or planning pregnancy during follow-up
- Body Mass Index over 35 kg/m2 or activities imposing high stress on implant
- Known smoker, vaper, alcohol or drug abuser within 180 days
- Previous participation and withdrawal from this trial
- Participation in another device, drug trial, or competitive study
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Karlie Morgan
CONTACT
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
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