Recruiting

Observational Study

Sponsor:

FX Shoulder Solutions

Code:

NCT06077942

Conditions

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Osteoarthritis Shoulder

Fracture, Shoulder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

FX Artificial Shoulder Prosthesis

Study Details

Brief summary:

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

Conditions

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Osteoarthritis Shoulder

Fracture, Shoulder

Study ID

NCT06077942

Start date

Dec 6, 2022

Status verified date

Oct, 2023

Completion date

Dec 30, 2032

Anticipated

Primary completion date

Dec 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.

Exclusion Criteria:

  • Patient who does not meet the inclusion criteria above

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 and distributed 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, PRCT II Fracture Plate, V-135

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 and Locations

Central contacts

Ted McKittrick, BA

7242493364tmckittrick@fxshouldersolutions.com

Brian Rogers, BS

18002800775brogers@fxsholudersolutions.com

Locations

Advanced Orthopedics Institute

Recruiting

The Villages, Florida, United States, 32159

Contacts

Kevin Trier, BS

727-735-1484KTC@goaoi.com

Ted McKittrick

7242493364tmckittrick@fxshouldersolutions.com

Principal Investigator:

Alfred J Cook, MD

More Information

Sponsor

FX Shoulder Solutions

Last update posted

Oct 12, 2023

Last verified

Oct, 2023

Keywords

  • Osteoarthritis
  • Roartator Cuff
  • Fracture
  • Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by FX Shoulder Solutions on 2023-10-12.