FX Shoulder Solutions Retrospective / Prospective Clinical Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06077942
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

FX Shoulder Solutions
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brian Rogers, BS
Principal Investigator Affiliation FX Shoulder Solutions
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
Additional Details

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To 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. Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study. Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.

Arms & Interventions

Arms

: Subjects

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

Interventions

Device: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OrthoArizona, Gilbert, Arizona

Status

Not yet recruiting

Address

OrthoArizona

Gilbert, Arizona, 85297

Site Contact

Justin Meyers

[email protected]

480-964-2908

Advanced Orthopedics Institute, The Villages, Florida

Status

Recruiting

Address

Advanced Orthopedics Institute

The Villages, Florida, 32159

Site Contact

Kevin Trier, BS

[email protected]

727-735-1484