FX Shoulder Prospective Clinical Study

FX Shoulder Solutions

Status

Enrolling

Conditions

Fracture, Shoulder

Osteoarthritis Shoulder

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Treatments

Device: FX Artificial Shoulder Prosthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT06078865

FXShoulder2020-01

FXShoulder2020-1 (Other Identifier)

Details and patient eligibility

About

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

Full description

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices and demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices.

To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.

To provide data and analysis for presentations, abstracts, publications and other public release of results.

A patient is considered a success at minimum of 2 years post-operative follow-up based upon the following composite clinical success (CCS):

Adjusted Constant Score that is ≥ 54 and improvement of ≥ 10 points from baseline Confidential FX Shoulder Post-Market Follow-Up Clinical Protocol Version 1.0 04 Aug 2022 9
No continuous radiolucency or device migration/subsidence
No revision surgery
No serious device related adverse event

The Registry will continue to follow patients to 5 years post-operative to track survivorship.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.