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AETOS Shoulder System

NCT06319911 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-05-07

No results posted yet for this 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

Conditions

  • Shoulder Osteoarthritis
  • Shoulder Arthritis

Interventions

DEVICE

AETOS

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

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Kolja Boese · Smith & Nephew, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2027-08-30
Completion
2030-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319911 on ClinicalTrials.gov