Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • OsseoFit Stemless Inlay
  • OsseoFit Stemless Onlay

Treatment groups

136 Participants
are divided into 2 treatment groups

Locations

1
The Research Foundation for the State University of New York14228, BuffaloNew York, United States

Sponsors and collaborators

Zimmer Biomet

Lead sponsor

Source ClinicalTrials.gov