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NCT06077942 | RECRUITING | Rotator Cuff Syndrome of Shoulder and Allied Disorders


FX Shoulder Solutions Retrospective / Prospective Clinical Study
Sponsor:

FX Shoulder Solutions

Brief Summary:

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

Condition or disease

Rotator Cuff Syndrome of Shoulder and Allied Disorders

Osteoarthritis Shoulder

Fracture, Shoulder

Intervention/treatment

FX Artificial Shoulder Prosthesis

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 600 participants
Official Title : FX Shoulder Solutions Retrospective / Prospective Clinical Study
Actual Study Start Date : 2022-12-06
Estimated Primary Completion Date : 2032-12-30
Estimated Study Completion Date : 2032-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

FX Shoulder Solutions Retrospective / Prospective Clinical Study

Location Details

NCT06077942


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


NOT YET RECRUITING

United States, Arizona

OrthoArizona

Gilbert, arizona, United States, 85297

RECRUITING

United States, Florida

Advanced Orthopedics Institute

The Villages, Florida, United States, 32159

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