Recruiting

AETOS

Sponsor:

Smith & Nephew, Inc.

Code:

NCT06319911

Conditions

Shoulder Osteoarthritis

Shoulder Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AETOS

Study Details

Brief 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

Conditions

Shoulder Osteoarthritis

Shoulder Arthritis

Study ID

NCT06319911

Start date

Mar 5, 2024

Status verified date

May, 2024

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

-

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).
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.

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Anatomic

Those subjects who have the AETOS implanted in the Primary Anatomic configuration

Primary reverse

Those subjects who have AETOS implanted in the Reverse configuration

Interventions

AETOS

The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration

Primary outcome measure

  • Implant Survivorship [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

California Pacific Orthopedics

Recruiting

San Francisco, California, United States, 94118

Contacts

Principal Investigator:

James Kelly, MD

Western Orthopaedics

Recruiting

Denver, Colorado, United States, 80210

Contacts

Principal Investigator:

Armand Hatzidakis

Hughston Foundation

Recruiting

Columbus, Georgia, United States, 31909

Contacts

Principal Investigator:

Brent Ponce

Center for Orthopedics and Neurosurgical Care

Recruiting

Bend, Oregon, United States, 97701

Contacts

Principal Investigator:

Scott Jacobson, MD

Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Brooke Olin

267-516-9393

Principal Investigator:

Matthew Ramsey, MD

More Information

Sponsor

Smith & Nephew, Inc.

Last update posted

May 7, 2024

Last verified

May, 2024

Keywords

  • Shoulder
  • arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Smith & Nephew, Inc. on 2024-05-07.