Evaluating the AETOS Shoulder System for shoulder replacement surgeries

AETOS Shoulder System Post Market Clinical Investigation

This study is testing the AETOS Shoulder System to see if it is safe and effective for people with shoulder arthritis who need shoulder replacement surgery.

Quick facts

• Study type: Observational
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Smith & Nephew, Inc. (Industry-sponsored)
• Locations: 5 sites (San Francisco, California and 4 other locations)
• Trial ID: NCT06319911 on ClinicalTrials.gov

What this trial studies

This observational study aims to confirm the safety and performance of the AETOS Shoulder System for shoulder arthroplasty in patients with shoulder osteoarthritis and arthritis. It will enroll up to 220 subjects across multiple centers in the USA, focusing on both anatomic and reverse shoulder replacement procedures. The study is non-comparative and will not include a randomization process, allowing for a direct assessment of the AETOS system's effectiveness in real-world settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require primary elective anatomic or reverse shoulder replacement due to conditions like rheumatoid arthritis or degenerative joint disease.

Not a fit: Patients who are undergoing revision surgeries or do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective option for patients undergoing shoulder replacement surgeries.

How similar studies have performed: Other studies evaluating shoulder arthroplasty systems have shown promising results, indicating that this approach is supported by prior successful investigations.

Eligibility criteria

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.

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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.

Where this trial is running

San Francisco, California and 4 other locations

• California Pacific Orthopedics — San Francisco, California, United States (Recruiting)
• Western Orthopaedics — Denver, Colorado, United States (Recruiting)
• Hughston Foundation — Columbus, Georgia, United States (Recruiting)
• Center for Orthopedics and Neurosurgical Care — Bend, Oregon, United States (Recruiting)
• Rothman Institute — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Tammy Clark, MPH

Conditions Shoulder Osteoarthritis; Shoulder Arthritis; Shoulder; arthroplasty