FX Shoulder Solutions Retrospective / Prospective Clinical Study

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
FX Shoulder Solutions
Study ID
NCT06077942
Status
Recruiting
Apply to this trial

Conditions

  • Fracture, Shoulder
  • Osteoarthritis Shoulder
  • Rotator Cuff Syndrome of Shoulder and Allied Disorders

Eligibility Criteria

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

Interventions

  • FX Artificial Shoulder Prosthesis — DEVICE
    Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, PRCT II Fracture Plate, V-135

Study Details

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

Key Dates

Start date
Dec 6, 2022
Status verified
Oct 2023
Primary completion
Dec 30, 2032
Completion
Dec 30, 2032

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Subjects
    Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

Primary Outcome Measure

Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments. [ Time Frame: 10 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OrthoArizonaGilbertArizona85297
Justin Meyers
[email protected]
480-964-2908
Lauren Quarles
[email protected]
480 284-4658
William Paterson, MD (PRINCIPAL_INVESTIGATOR)
Advanced Orthopedics InstituteThe VillagesFlorida32159
Kevin Trier, BS
[email protected]
727-735-1484
Ted McKittrick
[email protected]
7242493364
Alfred J Cook, MD (PRINCIPAL_INVESTIGATOR)

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By research site
OrthoArizona· Gilbert, AZAdvanced Orthopedics Institute· The Villages, FL

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