AETOS Shoulder System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patient is at least 18 years of age at the time of consent and skeletally mature.
Rheumatoid arthritis, and/or
Traumatic arthritis (Post Traumatic arthritis), and/or
Non-inflammatory degenerative joint disease, and/or
Disqualifiers
Patient has a contraindication to AETOS.
Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
Patient is indicated for a Hemiarthroplasty.
Patient has traumatic injury or a fracture.
Trial population
Males and females who are at least 18 years of age at the time of consent, are skeletally mature, and are indicated for primary anatomic or primary reverse will be enrolled in the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AETOS
DeviceThe AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Primary Anatomic1 intervention
Group B: Primary reverse1 intervention
Trial outcomes
Primary outcomes
1
Implant Survivorship
Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component
Time frame
2 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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.
Time frame
Day 0, 1 year, 2 years, and 5 yearsSponsors and contacts
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Source ClinicalTrials.gov