AETOS Shoulder System

N/ARecruitingNCT06319911

Smith & Nephew, Inc.220 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Shoulder Osteoarthritis Shoulder Arthritis

Interventions

AETOSDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

California Pacific Orthopedics

San Francisco, California, United States

RECRUITING

Western Orthopaedics

Denver, Colorado, United States

RECRUITING

Hughston Foundation

Columbus, Georgia, United States

Outcomes

Primary Outcomes

Implant Survivorship

Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component

Time frame: 2 years

Secondary Outcomes

Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years

Implant Survivorship at 6 months, 1 year, 3.5 years, and 5 years defined as absence of device removal or revision of any component

Time frame: 6 months, 1 year, 3.5 years, and 5 years

Radiographic Assessment - Glenoid Migration/Subsidence

Glenoid Component Migration / Subsidence collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions: 0\. Absent: No evidence of glenoid component displacement ≥ 5 mm relative to the native bone stock. 1\. Present: Presence of glenoid component displacement ≥ 5 mm relative to the native bone stock.

Time frame: Day 0, 1 year, 2 years, and 5 years

Radiographic Assessment - Glenoid Radiolucency

Glenoid Component Radiolucency - antero-posterior (AP) collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions: 0\. Absent: No evidence of radiolucency \> 2 mm in width along the bone-implant / bone-cement interface in any zone. 1\. Present: Presence of radiolucency \> 2 mm in width along the bone-implant / bone-cement interface in one or more zones.

Time frame: Day 0, 1 year, 2 years, and 5 years

Radiographic Assessment - Humeral Radiolucency

Humeral Component Radiolucency - AP collected post-surgery at day 0, 1 year, 2 years, and 5 years will be graded in accordance with the following definitions: 0\. Absent: No evidence of radiolucency \> 2 mm in width along the bone-implant interface in any zone. 1\. Present: Presence of radiolucency \> 2 mm in width along the bone-implant interface in one or more zones.

Central Contacts

Tammy Clark, MPH

CONTACT

3512269585 tammy.clark@smith-nephew.com

Karlie Morgan

CONTACT

5124967507 karlie.morgan@smith-nephew.com

Data from ClinicalTrials.gov

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