AETOS Shoulder System

Last updated: May 6, 2024
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

AETOS

Clinical Study ID

NCT06319911
AETOS 2022.04
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 replacementsurgery 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 visitsdetailed 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 allfollow-up visits. 5. Patient has been adequately informed of risks and requirements of the study and iswilling and able to provide informed consent for participation.

Exclusion

Exclusion Criteria: Patients who meet any of the following criteria will not qualify for participation in thetrial:

  1. Patient has a contraindication to AETOS.
  2. Patient is undergoing a revision shoulder replacement surgery including total orpartial 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 theimplant.
  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 theimplant and/or a chance of fracture.
  9. Patient has rapid joint destruction, marked bone loss or bone resorption (e.g., severeosteoporosis).
  10. Patient has osteomalacia.
  11. Patient has muscular, neurologic, or vascular deficiencies that may compromise theoutcome of the shoulder replacement surgery.
  12. Patient has a known sensitivity, allergic reaction, and/or known allergies to one ormore of the implanted materials.
  13. Patient has a distant foci of infection which may spread to the implant site, activelocal or systemic infection, sepsis, or osteomyelitis.
  14. Patient has an elevation of sedimentation rate, elevation of WBC count, or markedshift in WBC differential count unexplained by other disease.
  15. If reverse shoulder arthroplasty, patient has a non-functional deltoid or externalrotator muscles.
  16. If reverse shoulder arthroplasty, patient has a significant injury to the upperbrachial 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 followingdirections, or is a vulnerable subject per ISO 14155 (i.e., individuals who are unableto fully understand all aspects of the investigation that are relevant to the decisionto participate, or who could be manipulated or unduly influenced as a result of acompromised 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 theoutcome of the shoulder replacement surgery.
  21. Patient has anticipated activities which would impose high stresses on the implant andits fixation or has a high likelihood of a fall.
  22. Patient is a known smoker, vaper, alcohol abuser, or drug abuser within 180 days ofconsent.
  23. Patient has participated previously in this clinical trial and was withdrawn.
  24. Patient is participating in another device or drug trial or observational competitivestudy.

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: AETOS
Phase:
Study Start date:
March 05, 2024
Estimated Completion Date:
August 30, 2030

Study 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.

Connect with a study center

  • California Pacific Orthopedics

    San Francisco, California 94118
    United States

    Active - Recruiting

  • Western Orthopaedics

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • Hughston Foundation

    Columbus, Georgia 31909
    United States

    Active - Recruiting

  • Center for Orthopedics and Neurosurgical Care

    Bend, Oregon 97701
    United States

    Active - Recruiting

  • Rothman Institute

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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