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FX Shoulder Solutions Shoulder Replacement Study

This study is looking at how well different FX Shoulder Solutions artificial shoulder replacement devices work for people with shoulder conditions like rotator cuff problems, arthritis, or fractures. The devices being studied include the 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, and V-135. You might be able to join if you had one of these devices implanted between January 1, 2018, and June 30, 2023, because your surgeon determined it was the right treatment for you. The study will measure success by looking at your reported outcomes and how well your shoulder moves at least two years after surgery. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will collect information about people who have already received these shoulder replacement devices. It aims to include 600 participants.
What's involved
Researchers will collect information from your clinic notes and patient files about your demographics, shoulder status before surgery, the surgery itself, and any completed follow-up data. You will also have evaluations at specific times after your surgery.
Compensation
Not stated in the trial record.
Follow-up
The study will assess your outcomes at a minimum of 2 years after your surgery, with the primary endpoint measured at 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06077942

FX Shoulder Solutions Retrospective / Prospective Clinical Study

Recruiting
Not specifiedAll AgesObservational
FX Shoulder Solutions
~600 participants
Updated 2023-10-12 on ClinicalTrials.gov
What's tested:FX Artificial Shoulder Prosthesis

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.
Measured over 10 years

Conditions

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

Explore related trials

FractureLeft rotator cuff syndromeOsteoarthritis

Where it's being run

2 sites across 2 states
Arizona1
Florida1

Study leadership

  • Brian Rogers, BS · STUDY_DIRECTOR · FX Shoulder Solutions

Who to contact

Ted McKittrick, BA
[email protected]
7242493364
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Number of participants who are at a minimum of 2 years postoperative follow-up based upon the following composite clinical success (CCS) of the Patient Reported Outcome Surveys and Investigator Range of Motion (ROM) assessments.10 years

    * Adjusted Constant Score \> 70 * No continuous radiolucency or device migration/subsidence * No revision surgery or removal * No serious device related adverse event The Study will continue to follow patients prospectively to 10 years postoperative to track survivorship.