NL-OMON56814
Not yet recruiting
Not Applicable
A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation - TSA with Exactech with GPS or conventional instrumentation: an RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Exactech, Inc.
- Enrollment
- 220
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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, 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.
Outcomes
Primary Outcomes
Not specified
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