FX Shoulder Prospective Clinical Study

Last updated: October 5, 2023
Sponsor: FX Shoulder Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

FX Artificial Shoulder Prosthesis

Clinical Study ID

NCT06078865
FXShoulder2020-01
FXShoulder2020-1
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Receive an FX shoulder replacement medical device in accordance with the Indications forUse for the selected device system.

Exclusion

Exclusion Criteria: Patient who does not meet the inclusion criteria.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: FX Artificial Shoulder Prosthesis
Phase:
Study Start date:
March 31, 2021
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

  • OrthoArizona

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • First Settlement Orthopedics

    Marietta, Ohio 45750
    United States

    Active - Recruiting

  • Orthopedics Rhode Island

    Wakefield, Rhode Island 02879
    United States

    Active - Recruiting

  • Texas Orthopedic Specialists

    Bedford, Texas 76021
    United States

    Active - Recruiting

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