FX Shoulder Solutions Retrospective / Prospective Clinical Study

Last updated: October 10, 2023
Sponsor: FX Shoulder Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

FX Artificial Shoulder Prosthesis

Clinical Study ID

NCT06077942
FXShoulder2022-01
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patient who does not meet the inclusion criteria above

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: FX Artificial Shoulder Prosthesis
Phase:
Study Start date:
December 06, 2022
Estimated Completion Date:
December 30, 2032

Study 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.

Connect with a study center

  • OrthoArizona

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Advanced Orthopedics Institute

    The Villages, Florida 32159
    United States

    Active - Recruiting

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