Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty

Launched by EXACTECH · Nov 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for placing implants during a specific type of shoulder surgery called reverse shoulder arthroplasty. One method uses a new technology called Exactech Guided Personalized Surgery (GPS), while the other method uses the traditional approach. The goal is to find out which method helps place the implant more accurately and improves the movement of the shoulder after surgery. The researchers will follow participants for at least two years and up to ten years to see how they do over time.

To participate, you need to be at least 21 years old and have a reason to have this shoulder surgery. You should also be willing to attend all required follow-up visits and agree to the study rules. However, this trial is not for everyone; for instance, if you have had previous shoulder surgery for a fracture, have certain infections, or have specific health conditions that affect your shoulder, you may not be eligible. If you join the study, you can expect to undergo your surgery, have regular check-ups, and share your experiences about how your shoulder feels as you recover.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is at least 21 years of age at the time of surgery
• • Patient is indicated for reverse shoulder arthroplasty
• • Patient is willing to participate by complying with pre- and postoperative visit requirements
• • Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)
• • Patient is willing and able to review and sign a study informed consent form
• • Preop CT scan is within 3 months of the date of surgery
• Exclusion Criteria:
• • Revision shoulder arthroplasty
• • Reverse shoulder arthroplasty for fracture
• • Need for structural glenoid bone graft
• • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
• • Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
• • Neuromuscular disorders that do not allow control of the joint
• • Significant injury to the brachial plexus
• • Non-functional deltoid muscles
• • The patient is unwilling or unable to comply with the post-operative care instructions
• • Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.
• • Alcohol, drug, or other subtance abuse
• • Any disease state that could adversaly affect the function or longevity of the implant
• • Patient is pregnant
• • Patient is a prisoner
• • Patient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims