Humeral Head Implants for Shoulder Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial gathers data to ensure the safety and effectiveness of two shoulder implant components: the Comprehensive Primary Micro Stem and the Comprehensive Anatomic Versa-Dial Titanium Humeral Head, for both initial and follow-up shoulder surgeries. The goal is to evaluate the performance of these devices over a decade. Ideal participants have already undergone shoulder replacement surgery with these specific implants due to conditions like arthritis or shoulder fractures. As a Phase 4 trial, this research highlights that the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that both the Comprehensive Primary Micro Stem and the Comprehensive Anatomic Versa-Dial Titanium Humeral Head are generally well-tolerated by patients. These treatments have been in use since 2007, and studies have collected data to confirm their safety and effectiveness over time.
For the Comprehensive Primary Micro Stem, early results indicate that it performs as well as traditional shoulder treatments. Patients have experienced good outcomes, and the implant has proven stable and effective.
The Comprehensive Anatomic Versa-Dial Titanium Humeral Head uses advanced technology to provide flexibility during surgery. It is part of the Comprehensive Total Shoulder System, which offers various options for fitting the shoulder joint. This design emphasizes patient safety and adaptability.
While both treatments have demonstrated positive safety records, ongoing studies continue to gather more information about their long-term safety.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they offer innovative solutions for repairing shoulder malfunctions or diseases. The Comprehensive Anatomic Versa-Dial Titanium Humeral Head is special due to its adjustable design, which allows for a more personalized fit during shoulder replacement surgeries, potentially improving joint function and patient comfort. Meanwhile, the Comprehensive Primary Micro Stem stands out because of its minimally invasive implantation technique, which could lead to quicker recovery times compared to traditional shoulder surgery options. These advancements could provide more effective and patient-friendly alternatives to current standards like standard metal humeral heads and conventional stem implants.
What evidence suggests that the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads are effective for shoulder arthroplasty?
Research has shown that the Comprehensive Primary Micro Stem, one of the treatments in this trial, performs well in shoulder replacements. Studies confirm that this type of stem remains stable and provides good results over time. The short stem design, in particular, improves shoulder movement and secures the implant.
For the Comprehensive Anatomic Versa-Dial Titanium Humeral Head, another treatment option in this trial, past studies found it effective in shoulder surgeries. It offers flexibility during surgery and has demonstrated high success rates over time. Patients experienced better shoulder function and long-lasting implants. These findings support the potential effectiveness of both treatments for shoulder problems.34678Who Is on the Research Team?
Erin Osborn
Principal Investigator
Zimmer Biomet
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads for shoulder arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 5, 7, and 10 years
What Are the Treatments Tested in This Trial?
Interventions
- Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Comprehensive Primary Micro Stem
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral Heads to repair shoulder malfunction/disease.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zimmer Biomet
Lead Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
Ivan Tornos
Zimmer Biomet
Chief Executive Officer since 2023
MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business
Citations
Comprehensive® Total Shoulder System Early Clinical ...
The Comprehensive® Total Shoulder System allows for surgeon efficiency through intraoperative flexibility, multiple humeral stem options and infinite humeral.
A Study of the Comprehensive® Shoulder System with ...
primary shoulder replacement in conjunction with the 510(k) cleared Versa-Dial™ Humeral. Heads (K040610, K060716) and Comprehensive® Hybrid Glenoids (K060694).
K214001.pdf - accessdata.fda.gov
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture,. Primary and Revision), and the ...
Comprehensive Total Shoulder System Surgical Technique
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems. (Fracture, Primary and Revision), the Bio-Modular®.
a short stemmed humeral implant and hybrid glenoid
aTSA with the Comprehensive Shoulder System had a high survivorship rate at the 10-year follow-up with improved clinical results postoperative.
Comprehensive Primary/Micro Stem & Versa-Dial Ti ...
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, ...
7.
zimmerbiomet.com
zimmerbiomet.com/en/products-and-solutions/specialties/shoulder/comprehensive-total-shoulder-system.htmlComprehensive® Total Shoulder System
The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities.
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
This is a long-term, post-market study to gather safety and how well the Comprehensive Versa-Dial Reverse Titanium Glenosphere works when used in shoulder ...
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