RECRUITING

AETOS Shoulder System

Conditions

Shoulder Osteoarthritis Shoulder Arthritis Shoulder arthroplasty

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

AETOS Shoulder System Post Market Clinical Investigation

Quick Facts

Study Start:2024-03-05

Study Completion:2030-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06319911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 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). 10. Patient has osteomalacia. 11. Patient has muscular, neurologic, or vascular deficiencies that may compromise the outcome of the shoulder replacement surgery. 12. Patient has a known sensitivity, allergic reaction, and/or known allergies to one or more of the implanted materials. 13. Patient has a distant foci of infection which may spread to the implant site, active local or systemic infection, sepsis, or osteomyelitis. 14. Patient has an elevation of sedimentation rate, elevation of WBC count, or marked shift in WBC differential count unexplained by other disease. 15. If reverse shoulder arthroplasty, patient has a non-functional deltoid or external rotator muscles. 16. If reverse shoulder arthroplasty, patient has a significant injury to the upper brachial plexus. 17. If reverse shoulder arthroplasty, patient has paralysis of the axillary nerve. 18. Patient is uncooperative, has a neurologic disorder and is not capable of following directions, or is a vulnerable subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response). 19. Patient is pregnant or plans to become pregnant during the follow-up period. 20. Patient has a Body Mass Index (BMI) of \>35kg/m2 or a BMI that may compromise the outcome of the shoulder replacement surgery. 21. Patient has anticipated activities which would impose high stresses on the implant and its fixation or has a high likelihood of a fall. 22. Patient is a known smoker, vaper, alcohol abuser, or drug abuser within 180 days of consent. 23. Patient has participated previously in this clinical trial and was withdrawn. 24. Patient is participating in another device or drug trial or observational competitive study.

Inclusion Criteria

Exclusion Criteria

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. 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).
10. Patient has osteomalacia.
11. Patient has muscular, neurologic, or vascular deficiencies that may compromise the outcome of the shoulder replacement surgery.
12. Patient has a known sensitivity, allergic reaction, and/or known allergies to one or more of the implanted materials.
13. Patient has a distant foci of infection which may spread to the implant site, active local or systemic infection, sepsis, or osteomyelitis.
14. Patient has an elevation of sedimentation rate, elevation of WBC count, or marked shift in WBC differential count unexplained by other disease.
15. If reverse shoulder arthroplasty, patient has a non-functional deltoid or external rotator muscles.
16. If reverse shoulder arthroplasty, patient has a significant injury to the upper brachial plexus.
17. If reverse shoulder arthroplasty, patient has paralysis of the axillary nerve.
18. Patient is uncooperative, has a neurologic disorder and is not capable of following directions, or is a vulnerable subject per ISO 14155 (i.e., individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
19. Patient is pregnant or plans to become pregnant during the follow-up period.
20. Patient has a Body Mass Index (BMI) of \>35kg/m2 or a BMI that may compromise the outcome of the shoulder replacement surgery.
21. Patient has anticipated activities which would impose high stresses on the implant and its fixation or has a high likelihood of a fall.
22. Patient is a known smoker, vaper, alcohol abuser, or drug abuser within 180 days of consent.
23. Patient has participated previously in this clinical trial and was withdrawn.
24. Patient is participating in another device or drug trial or observational competitive study.

Contacts and Locations

Study Contact

Tammy Clark, MPH

CONTACT

3512269585

tammy.clark@smith-nephew.com

Karlie Morgan

CONTACT

5124967507

karlie.morgan@smith-nephew.com

Principal Investigator

Kolja Boese

STUDY_DIRECTOR

Smith & Nephew, Inc.

Study Locations (Sites)

California Pacific Orthopedics

San Francisco, California, 94118

United States

Western Orthopaedics

Denver, Colorado, 80210

United States

Hughston Foundation

Columbus, Georgia, 31909

United States

Center for Orthopedics and Neurosurgical Care

Bend, Oregon, 97701

United States

Rothman Institute

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Smith & Nephew, Inc.

Kolja Boese, STUDY_DIRECTOR, Smith & Nephew, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05

Study Completion Date2030-08-30

Study Record Updates

Study Start Date2024-03-05

Study Completion Date2030-08-30

Terms related to this study

Keywords Provided by Researchers

Shoulder
arthroplasty

Additional Relevant MeSH Terms

Shoulder Osteoarthritis
Shoulder Arthritis