fractures near the shoulder joint Shoulder degeneration
Conditions
Interventions
Implantation of Equinoxe® Shoulder System.
Since patients enrolled in this study will only have reverse shoulder
arthroplasty surgery, only reverse shoulder components will be used.
In one study ar
Sponsors
Exactech, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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, implementation 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alignment of the prosthesis (i.e., degree of accurate implant placement according to plan, using a postoperative CT scan to confirm position). | — |
Secondary
| Measure | Time frame |
|---|---|
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) Form and range of motion measurements at 3 months, 1 year, 2- year, 5-year, and 10-year postoperative timepoints. Radiographic outcomes from scans (e.g., radiolucent lines, notching, etc.) | — |
Countries
Netherlands
Outcome results
None listed