AETOS Shoulder System

Part of paid clinical trials in San Francisco, California.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT06319911
Status
Recruiting
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Conditions

  • Shoulder Arthritis
  • Shoulder Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 5, 2024
Status verified
May 2024
Primary completion
Aug 30, 2027
Completion
Aug 30, 2030

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: Primary Anatomic
    Those subjects who have the AETOS implanted in the Primary Anatomic configuration
  • Arm: Primary reverse
    Those subjects who have AETOS implanted in the Reverse configuration

Primary Outcome Measure

Implant Survivorship [ Time Frame: 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
California Pacific OrthopedicsSan FranciscoCalifornia94118
Katie Sheehi
[email protected]
415-668-8010
James Kelly, MD (PRINCIPAL_INVESTIGATOR)
Western OrthopaedicsDenverColorado80210
Libby Mauter
[email protected]
303-321-1333
Armand Hatzidakis (PRINCIPAL_INVESTIGATOR)
Hughston FoundationColumbusGeorgia31909
Cholly Minton
[email protected]
706-494-3330
Brent Ponce (PRINCIPAL_INVESTIGATOR)
Center for Orthopedics and Neurosurgical CareBendOregon97701
Cody Manriquez
[email protected]
541-420-0774
Scott Jacobson, MD (PRINCIPAL_INVESTIGATOR)
Rothman InstitutePhiladelphiaPennsylvania19107
Brooke Olin
267-516-9393
Matthew Ramsey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
California Pacific Orthopedics· San Francisco, CAWestern Orthopaedics· Denver, COHughston Foundation· Columbus, GACenter for Orthopedics and Neurosurgical Care· Bend, ORRothman Institute· Philadelphia, PA

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