Recruiting

Observational Study

Sponsor:

FX Shoulder Solutions

Code:

NCT06078865

Conditions

Osteoarthritis Shoulder

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Fracture, Shoulder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

FX Artificial Shoulder Prosthesis

Study Details

Brief summary:

Prospective Multi-Center Registry on study subjects with implanted devices marketed and legally commercialized in the USA by FX Shoulder Solutions.

Conditions

Osteoarthritis Shoulder

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Fracture, Shoulder

Study ID

NCT06078865

Start date

Mar 31, 2021

Status verified date

Feb, 2026

Completion date

Dec 30, 2031

Anticipated

Primary completion date

Dec 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system.

Exclusion Criteria:

Patient who does not meet the inclusion criteria.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects

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

Interventions

FX Artificial Shoulder Prosthesis

Humelock II Anatomic Shoulder System, Humelock II Reversible Shoulder System, Humelock Reverse Shoulder System, Humeris Shoulder System, Easytech Anatomical Shoulder System, FXV135 Mini Shoulder System, FXV135 Humelock Shoulder System

Primary outcome measure

  • A patient is considered a success at post-operative follow-up based upon the following composite clinical success (CCS): [ Time Frame: 2 years ]
  • Survivorship [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Brian Wasonga, MHA

800-280-0775bwasonga@fxshouldersolutions.com

Brian Rogers, BS

800 280-0775brogers@fxsholudersolutions.com

Locations

OrthoArizona

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

William Paterson, MD

480 284-4658wpaterson@orthoarizona.org

lquarles@orthoarizona.org

Principal Investigator:

William Paterson, MD

First Settlement Orthopedics

Recruiting

Marietta, Ohio, United States, 45750

Contacts

Angie Miller, FNP-BC

740 373-8456angie_d_miller@yahoo.com

Joette Fetty, CPC

740 373-8756joefetty@mhsystem.org

Principal Investigator:

John Henry, MD

Orthopedics Rhode Island

Recruiting

Wakefield, Rhode Island, United States, 02879

Contacts

Jennifer Stedman

401 777-7000jstedman@orthopedicsri.com]

Principal Investigator:

Michael Bradley, MD

Texas Orthopedic Specialists

Recruiting

Bedford, Texas, United States, 76021

Contacts

Amber Morgan

817.510.4022amber@txortho.net

Principal Investigator:

Howard Harris, MD

More Information

Sponsor

FX Shoulder Solutions

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Osteoarthritis
  • Fracture
  • rotator cuff tear
  • shoulder trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by FX Shoulder Solutions on 2026-02-09.