Evaluating the AETOS Shoulder System for shoulder replacement surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tammy.clark@smith-nephew.com
• Phone: 3512269585

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Zimmer Biomet Shoulder Replacement Systems

  This study is testing how safe and effective Zimmer Biomet Shoulder Replacement Systems are for people getting shoulder surgery, looking at how well the implants last over ten years and how patients feel after two years.

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• Cryoneurolysis for Chronic Pain: 6- and 12-Month Outcomes in Routine Care

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• Shoulder replacement techniques: comparing anatomic vs. reverse in people with shoulder arthritis and a healthy rotator cuff

  This study tests whether anatomic total shoulder arthroplasty (aTSA) leads to better patient-reported outcomes after 1 year than reverse total shoulder arthroplasty (rTSA) for people with shoulder arthritis and an intact rotator cuff.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07584356

• Steroid injections into myofascial trigger points versus joint injections for shoulder osteoarthritis

  This study will test whether steroid injections into muscle trigger points work as well as steroid injections into the shoulder joint for adults with shoulder osteoarthritis and ongoing shoulder pain.

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• Using a wearable device to manage work-related shoulder pain

  This study is testing a wearable device that helps workers with shoulder pain by giving them feedback on their movements to see if it can make their pain and work limitations better.

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• Personalized mobile health app to aid recovery after reverse shoulder arthroplasty

  A personalized mobile app is tested to see if tailored information and rehab guidance help people recover better after reverse shoulder arthroplasty compared with standard care.

  Recruiting at 2 sites VieCuri Medical Centre · Venlo, Limburg and 1 other locations · NCT06520085

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.