New stemless shoulder implant aims to improve mobility and reduce pain
NCT ID NCT07421245
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
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2036
An estimate. End dates often move.
- Lead sponsor
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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
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Summit Medical Group P.A. dba Summit
Florham Park, New Jersey, 07932, United States
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The Research Foundation for the State University of New York
Buffalo, New York, 14228, United States
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