Loading clinical trials...

AETOS Shoulder System | Clinical Trials | Clareo Health

RECRUITING

AETOS Shoulder System

AETOS Shoulder System Post Market Clinical Investigation

NCT06319911•Smith & Nephew, Inc.

Summary

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

Detailed Description

This study will confirm the safety and performance of the AETOS Shoulder System in anatomic and reverse TSA. Revisions will not be enrolled into this study. The AETOS Shoulder System is manufactured by Smith \& Nephew, Inc., 1450 Brooks Road Memphis, Tennessee 38116 USA, and has been 510k Cleared as of 07Jun2023; therefore, it is considered a post-market product and will be procured through normal commercial channels in the USA. The humeral stem is designed to be used for both Total Shoulder Arthroplasty (TSA) and reverse shoulder arthroplasty procedures. The humeral stems are designed with fins and a porous plasma coating to provide fixation within the proximal humeral metaphysis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all the following criteria to be included in the study:
•1. Patient is at least 18 years of age at the time of consent and skeletally mature.
•2. Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:
•* Rheumatoid arthritis, and/or
•* Traumatic arthritis (Post Traumatic arthritis), and/or
•* Non-inflammatory degenerative joint disease, and/or
•* Correction of functional deformity.
•3. Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy.
•4. Patient is geographically stable and willing to return to the study site for all follow-up visits.
•5. Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.
+1 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will not qualify for participation in the trial:
•1. Patient has a contraindication to AETOS.
•2. Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
•3. Patient is indicated for a Hemiarthroplasty.
•4. Patient has traumatic injury or a fracture.
•5. Patient has uncontrolled diabetes with a hemoglobin A1C of 7.5 or greater.
•6. Patient has comorbidities/conditions that preclude proper healing/fixation of the implant.
•7. Patient has poor quality or insufficient bone stock to support the implant.
•8. Patient has poor bone quality where there could be considerable migration of the implant and/or a chance of fracture.
•9. Patient has rapid joint destruction, marked bone loss or bone resorption (e.g., severe osteoporosis).
+15 more criteria

Locations (5)

California Pacific Orthopedics

San Francisco, California, United States

Western Orthopaedics

Denver, Colorado, United States

Hughston Foundation

Columbus, Georgia, United States

Center for Orthopedics and Neurosurgical Care

Bend, Oregon, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 5, 2024

Primary Completion Date

August 30, 2027

Completion Date

August 30, 2030

Last Updated

May 7, 2024

Enrollment

220

ESTIMATED participants

Conditions

Shoulder OsteoarthritisShoulder Arthritis

Interventions

AETOS

DEVICE

Contacts

Tammy Clark, MPH

CONTACT

3512269585 tammy.clark@smith-nephew.com

Karlie Morgan

CONTACT

5124967507 karlie.morgan@smith-nephew.com

CBD for Pain Following Orthopedic Shoulder Surgery

NCT06381791

Shoulder OsteoarthritisRotator Cuff Injuries

View study

ENROLLING_BY_INVITATION

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

NCT04003311

Shoulder PainShoulder Injuries+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AETOS Shoulder System

Inclusion Criteria

Exclusion Criteria

CBD for Pain Following Orthopedic Shoulder Surgery

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions

Effect of Corticosteroid Injections on Blood Glucose

Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty

Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application