Exactech GPS

Study added: 25 Sep 2020

Study Contact:

Kaitlyn Shank 434-243-5653 Lizzie Leitch 434-243-0256

IRB 21220- Werner (Brockmeier sub-I)

Patient is at least 21 years of age at the time of surgery
Patient is indicated for a reverse shoulder arthroplasty
Patient is willing to participate by complying with pre- and postoperative visit requirements
Patient is willing to participate the entire length of the prescribed follow-up (minimum 2 years)
Patient has had pre-op CT scan within 3 months of the date of surgery

Patient with revision arthroplasty
Patient with reverse shoulder arthroplasty or fracture
Patient with need for structural glenoid bone graft
Patient with osteomyelitis of the proximal humerus or scapula
Patient with inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
Patient with neuromuscular disorders that do not allow control of the joint
Patient with significant injury to the brachial plexus
Patient with non-functional deltoid muscles
Patient is unwilling or unable to comply with post-operative care instructions
Patient who is a known drug or alcohol abuser or has a psychological disorder as defined by the DSM4 that would affect follow-up care or treatment outcomes
Patient with any disease state that could adversely affect the function or longevity of the impact
Patient who is pregnant
Patient who is a prisoner
Patient who are currently involved in any personal injury litigation, medical-legal or workman’s compensation claims

Baseline: Consent, review of inclusion/exclusion criteria, questionnaires, x-ray, CT scan (within 3mo of surgery; can use SOC scan if within 3 month window)
Surgery: randomization and device accountability (Tim Zieden collecting stickers in OR for us; email: Richmondorthoflex@gmail.com)
3 Month: CT scan, x-ray, shoulder exam and questionnaires
1 Year: X-ray, shoulder exam and questionnaires
2 Year: X-ray, shoulder exam and questionnaires
5 Year: X-ray, shoulder exam and questionnaires
10 Year: X-ray, shoulder exam and questionnaires

Covered by patient/ insurance: baseline clinic visit, CT scan (if already done as SOC), 1 year visit and x-rays
Covered by the study: clinic visits at 2, 5, and 10 year visits, x-rays at 2, 5, and 10 year visits, 3-month CT scan