FX Shoulder Solutions Retrospective / Prospective Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-06

Study Completion Date

2032-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects

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

FX Artificial Shoulder Prosthesis

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No