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New stemless shoulder implant aims to improve mobility and reduce pain

NCT ID NCT07421245

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study is testing a new shoulder implant that doesn't use a stem, designed for people with arthritis or shoulder damage. About 136 adults will receive the implant and be followed for 2 years to see if it improves shoulder function and pain. The goal is to confirm the implant is safe and works well for everyday activities.

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 136 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2036

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

The OsseoFit Stemless Shoulder implants are intended for shoulder joint arthroplasty. OsseoFit™ Stemless Shoulder humeral components have a porous surface and are indicated for uncemented biological fixation applications. Compatible Glenoid components are intended to be implanted with bone cement. The porous posts may be inserted without bone cement. Compatible Comprehensive Convertible Glenoid components are intended for cementless applications with the addition of screw fixation.

Ages

20 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: * Patient must be 20 years of age or older. * The patient must be anatomically and structurally suited, as evident by scapula and proximal humerus closure, to receive the implants. * Patient planned to receive OsseoFit™ anchor with uncemented fixation. * Patient planned to receive a Modular Alliance Glenoid with bone cement. The porous posts must be coated with Porous Plasma Spray (PPS) and may be inserted without bone cement. * Patient planned to receive shoulder arthroplasty due to osteoarthritis. * Patient must be able and willing to complete the protocol required follow-up schedule. * Patient must be able and willing to sign the IRB approved consent. Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study. * Patient is known to be pregnant or breastfeeding. * Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant). * Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient has any neuromuscular disease compromising the affected limb. * Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include: * Local/systemic infection * Sepsis * Osteomyelitis * Patient presents with Osteomalacia. * Patient presents with a humeral bone fracture. * Patient presents with malunion or non-union of the tuberosities of the proximal humerus. * Patient has had a previous operative shoulder prosthesis (stem or stemless). * Patient has irreparable cuff tear. * Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to: * Osteoporosis * Extensive Avascular Necrosis * Rheumatoid Arthritis * Metaphyseal bony defects (including large cysts)

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Conditions

The condition(s) this trial relates to.

osteoarthritis Shoulder Fractures Shoulder Injuries Shoulder Pain

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 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

  • Summit Medical Group P.A. dba Summit

    Florham Park, New Jersey, 07932, United States

  • The Research Foundation for the State University of New York

    Buffalo, New York, 14228, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.