Actively Recruiting
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
Led by Exactech · Updated on 2025-02-28
260
Participants Needed
1
Research Sites
574 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Revision shoulder arthroplasty
- Reverse shoulder arthroplasty for fracture
- Need for structural glenoid bone graft
- Osteomyelitis of the proximal humerus or scapula; systemic or secondary remote infections must be resolved before implantation
- Inadequate or malformed bone that prevents proper implant support or fixation
- Neuromuscular disorders that impair joint control
- Significant injury to the brachial plexus
- Non-functional deltoid muscles
- Unwillingness or inability to comply with post-operative care instructions
- Known drug or alcohol abuse or psychological disorders affecting follow-up care
- Alcohol, drug, or other substance abuse
- Any disease that could negatively impact implant function or lifespan
- Pregnancy
- Being a prisoner
- Current involvement in personal injury litigation, medical-legal, or worker's compensation claims
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dijklander Ziekenhuis
Hoorn, Netherlands, 1624 NP
Actively Recruiting
Research Team
R
Rachael Craig
CONTACT
S
Sandrine Angibaud
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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