A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentatio

• Conditions: fractures near the shoulder joint; Shoulder degeneration; 10023213

• Registration Number: NL-OMON56814
• Lead Sponsor: Exactech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 220

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.
Non-functional deltoid muscles.
The patient is unwilling or unable to comply with the post-operative care
instructions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified