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Shoulder implant safety tracked for years after surgery

NCT ID NCT05049993

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study follows 76 people who received a pyrocarbon shoulder implant to see how well it works and holds up over 5 to 10 years. Researchers measure shoulder pain, function, and any complications. The goal is to confirm the implant is safe and effective for long-term use.

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

76 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Dec 2027

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

Long-term follow-up of Pyrocarbon IDE patients.

Ages

22 years and older

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: * Subject in the Pyrocarbon IDE Study and has not had the device explanted. * Patient informed, willing, and able to sign an informed consent form approved by IRB or EC * Willing and able to comply with the requirements of the study protocol Exclusion Criteria: • Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Allina Health Orthopedics

    Minneapolis, Minnesota, 55407, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • HCA HealthONE, LLC

    Denver, Colorado, 80218, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • Missouri Orthopaedic Institute

    Columbia, Missouri, 65211, United States

  • Southern Maryland Orthopedics

    Waldorf, Maryland, 20602, United States

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

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