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Primary reverse for Shoulder Osteoarthritis

N/A
Recruiting
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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

Eligible Conditions
  • Shoulder Osteoarthritis
  • Shoulder Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implant Survivorship
Secondary outcome measures
American Shoulder and Elbow Score (ASES)
Constant Murley Score
Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary reverseExperimental Treatment1 Intervention
Those subjects who have AETOS implanted in the Reverse configuration
Group II: Primary AnatomicExperimental Treatment1 Intervention
Those subjects who have the AETOS implanted in the Primary Anatomic configuration

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
165 Previous Clinical Trials
22,261 Total Patients Enrolled
Kolja BoeseStudy DirectorSmith & Nephew, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
AETOS Shoulder System
2024. "AETOS Shoulder System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06319911.
All > Paid Studies Baltimore > Colorado Springs
~147 spots leftby Aug 2027
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