OsseoFit Stemless Shoulder System (Anatomic) (NCT07421245) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OsseoFit Stemless Shoulder System (Anatomic)
United States136 participantsStarted 2026-04
Plain-language summary
The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the American Shoulder and Elbow Surgeons (ASES) Shoulder Score