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NCT05615259
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
Conditions: Technology, Comparison
Sex: All
Ages: 21 Years – N/A
Enrollment: 260
Sponsor: Exactech
Location: United States
Summary
The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques.
The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes.
Long-term follow-up to 10 years with minimum 2 year follow-up for patients.
Eligibility Criteria
Inclusion Criteria:Patient is at least 21 years of age at the time of surgeryPatient is indicated for reverse shoulder arthroplastyPatient is willing to participate by complying with pre- and postoperative visit requirementsPatient 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 formPreop CT scan is within 3 months of the date of surgeryExclusion Criteria:Revision shoulder arthroplastyReverse shoulder arthroplasty for fractureNeed for structural glenoid bone graftOsteomyelitis 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 resolvedInadequate or malformed bone that precludes adequate support or fixation of the prosthesisNeuromuscular disorders that do not allow control of the jointSignificant injury to the brachial plexusNon-functional deltoid musclesThe patient is unwilling or unable to comply with the post-operative care instructionsPatients 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 abuseAny disease state that could adversaly affect the function or longevity of the implantPatient is pregnantPatient is a prisonerPatient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims
Source: ClinicalTrials.gov (NCT05615259). StuddyBuddy aggregates publicly available trial information.