A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Medacta USA
Study ID
NCT07812324
Status
Not Yet Recruiting

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Conditions

  • Shoulder Arthroplasty
  • Total Shoulder Arthroplasty

Eligibility Criteria

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

Interventions

  • Mirror Anatomic Total Shoulder Prosthesis — DEVICE
    Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
  • Medacta Anatomic Shoulder — DEVICE
    Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.

Study Details

This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.

Key Dates

First listed
Sep 10, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
286 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational)
  • Active Comparator: 143 patients undergoing implantation of Medacta Anatomic Shoulder (control)

Primary Outcome Measure

This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint [ Time Frame: 24 months of follow up ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
OrthoArizonaGilbertArizona85297
Austin Smith, MD (PRINCIPAL_INVESTIGATOR)
West Boca Medical CenterBoca RatonFlorida33428
Rosena Siquitte
[email protected]
Jonathan Levy, MD (PRINCIPAL_INVESTIGATOR)
Andrews Research & Education FoundationGulf BreezeFlorida32561
Meredith Yeager
[email protected]
Ellie Hartsfield
[email protected]
448-227-7309
Christopher O'Grady, MD (PRINCIPAL_INVESTIGATOR)
Foundation for Orthopedic Research and EducationTampaFlorida33607
Debbi Warren
[email protected]
Kevin Cronin, MD (PRINCIPAL_INVESTIGATOR)
Central Indiana OrthopedicsFishersIndiana46037
Brian Badman, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins - WashingtonColumbiaMaryland21044
Debra Chan
[email protected]
Umasuthan Srikumaran, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth HitchcockLebanonNew Hampshire03756
Holly Symonds
[email protected]
Daniel Austin, MD (PRINCIPAL_INVESTIGATOR)
Cornell Med NYNew YorkNew York10021
Jessica Rios
[email protected]
Theodore Blaine, MD (PRINCIPAL_INVESTIGATOR)
Southern Oregon OrthopedicsMedfordOregon97504
Lindsey Chin
[email protected]
NormaJean Hatten
[email protected]
Patrick Denard, MD (PRINCIPAL_INVESTIGATOR)
Penn MedicinePhiladelphiaPennsylvania19104
Ellen Stinger
[email protected]
Warren Harding
[email protected]
David Glaser, MD (PRINCIPAL_INVESTIGATOR)
Andrew Kuntz, MD (SUB_INVESTIGATOR)
University of Utah HospitalSalt Lake CityUtah84108
Ashley Neese
[email protected]
Peter Chalmers, MD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthSt. GeorgeUtah84790
Emily Piazza
[email protected]
Zachary Leitze, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gilbert, AZ

By research site
OrthoArizona· Gilbert, AZWest Boca Medical Center· Boca Raton, FLAndrews Research & Education Foundation· Gulf Breeze, FLFoundation for Orthopedic Research and Education· Tampa, FLCentral Indiana Orthopedics· Fishers, INJohns Hopkins - Washington· Columbia, MD

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