MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
Public ClinicalTrials.gov record NCT04003311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
Study identification
- NCT ID
- NCT04003311
- Recruitment status
- Enrolling by invitation
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 146 participants
Conditions and interventions
Interventions
- Comprehensive Primary Micro Stem Device
- Comprehensive Anatomic Versa-Dial Titanium Humeral Head Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2019
- Primary completion
- Jul 28, 2028
- Completion
- Jul 28, 2028
- Last update posted
- Oct 29, 2025
2019 – 2028
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shoulder Clinic of Idaho | Boise | Idaho | 83704 | — |
| Beaumont Health | Royal Oak | Michigan | 48073 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont | Burlington | Vermont | 05405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04003311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 29, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04003311 live on ClinicalTrials.gov.