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 range20 Years
SexALL
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 OsseoFitâ„¢ 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 …
What they're measuring
1
the American Shoulder and Elbow Surgeons (ASES) Shoulder Score