NCT04003272

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive Versa-Dial Reverse Titanium (Ti) Glenosphere in Primary, Fracture and Revision Total Shoulder Arthroplasty

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 59 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this retrospective/prospective consecutives 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 (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 Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data. \*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.

Detailed description

The objective of this retrospective/prospective consecutives 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 (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 Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Comprehensive Reverse Versa-Dial Titanium Glenosphere	Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.

Timeline

• Start date: 2019-10-28
• Primary completion: 2034-08-19
• Completion: 2035-09-01
• First posted: 2019-07-01
• Last updated: 2026-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study