MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Status Enrolling by invitation

Clinical Trial Summary

Clinical Trial Description

The objective of this retrospective/prospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty, fractures and revision total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7 and 10-year follow-up* to meet EU Medical Device and other regulatory requirements for post market surveillance. Because Comprehensive Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data. The primary objective 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04003272
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Enrolling by invitation
Phase
Start date	October 28, 2019
Completion date	July 29, 2029

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.