Actively Recruiting
A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation
Led by Exactech · Updated on 2025-02-28
260
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best way to position implants in reverse shoulder arthroplasty by comparing a new technology called Exactech Guided Personalized Surgery (GPS) with traditional surgical methods. This study aims to see how the implant placement affects shoulder range of motion and patient-reported outcomes. The study includes long-term follow-up of up to 10 years, with at least 2 years of monitoring for each patient. Participants will undergo reverse shoulder arthroplasty using either the GPS technique or conventional tools. The study will compare these two methods to see which allows for better implant positioning. Patients will have a preoperative CT scan taken within three months before surgery to assist in planning. The study involves regular follow-up visits to monitor progress and outcomes. Throughout the study, participants will be evaluated using several shoulder function and pain assessments, including SST-12, SPADI, Constant, ASES, and UCLA scores, with an average of one assessment per year. These measures will help researchers understand the impact of implant positioning on shoulder function and patient satisfaction. Participants must commit to attending follow-up visits for a minimum of two years, with some followed for up to ten years to assess long-term results.
CONDITIONS
Brief 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; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation 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
- Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.
- Alcohol, drug, or other subtance abuse
- Any disease state that could adversaly affect the function or longevity of the implant
- Patient is pregnant
- Patient is a prisoner
- Patient who are currently involved in any 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay duration
Participants undergo total shoulder arthroplasty surgery using either Exactech Guided Personalized Surgery (GPS) or conventional instrumentation, followed by immediate post-operative care.
1 surgical visit and hospital stay
Duration - Minimum 2 years
Participants are monitored through follow-up visits to assess recovery and shoulder function over a minimum of 2 years.
Approximately annual visits for up to 2 years
Trial Site Locations
Total: 1 location
1
Dijklander Ziekenhuis
Hoorn, Netherlands, 1624 NP
Actively Recruiting
Research Team
R
Rachael Craig
S
Sandrine Angibaud
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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