NCT04003311

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 146 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 1,2,3,5,7 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. The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs). \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Conditions

• Shoulder Pain
• Shoulder Injuries
• Shoulder Fractures
• Shoulder Disease
• Shoulder Arthritis

Interventions

Type	Name	Description
DEVICE	Comprehensive Primary Micro Stem	Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
DEVICE	Comprehensive Anatomic Versa-Dial Titanium Humeral Head	Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Timeline

• Start date: 2019-12-13
• Primary completion: 2028-07-29
• Completion: 2028-07-29
• First posted: 2019-07-01
• Last updated: 2025-10-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study