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600 patients to test new shoulder implants in Real-World study

NCT ID NCT06078865

Disease control Sponsor: FX Shoulder Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 600 people who receive an FX artificial shoulder implant for conditions like arthritis, rotator cuff problems, or shoulder fractures. Researchers will measure pain, shoulder function, implant survival, and any complications over time. The goal is to see how well these already-approved devices perform in everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FX Artificial Shoulder Prosthesis (a set of shoulder replacement implant systems)
What this could lead to
If successful, this could confirm that FX shoulder implants are safe and effective for long-term use in people with arthritis, rotator cuff issues, or fractures.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the implant is better than other options. Some patients may still have pain, complications, or need revision surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Receive an FX shoulder replacement medical device in accordance with the Indications for Use for the selected device system. Exclusion Criteria: Patient who does not meet the inclusion criteria.

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Conditions

The condition(s) this trial relates to.

bone fracture osteoarthritis Rotator Cuff Injuries rotator cuff syndrome Shoulder Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fracture, shoulder Osteoarthritis shoulder Rotator cuff syndrome of shoulder and allied disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Settlement Orthopedics

    RECRUITING

    Marietta, Ohio, 45750, United States

  • OrthoArizona

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Orthopedics Rhode Island

    RECRUITING

    Wakefield, Rhode Island, 02879, United States

  • Texas Orthopedic Specialists

    RECRUITING

    Bedford, Texas, 76021, United States

More trials for these conditions

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