NCT04474665

Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Spine Institute of Louisiana Foundation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.

Detailed description

The Blueprint planning software automatically creates a virtual implantation environment for the surgeon to use. The use of 3D measurements is independent of patient positioning, which results in more accurate measurements of the glenoid version and inclination measurements in shoulder replacement surgery. Pre-operative planning with Blueprint can accurately predict intraoperative implant selection within one size. Also, pre-operative planning leads to case efficiency and improved functional outcomes at 6 months post-operative compared to Baseline. The objective of this study is to characterize implant size accuracy, planning time, functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning software in subjects who are candidates for reverse shoulder arthroplasty.

Conditions

• Reverse Shoulder Replacement

Interventions

Type	Name	Description
DEVICE	Reverse shoulder arthroplasty utilizing Blueprint Software	Reverse shoulder arthroplasty utilizing Blueprint Software

Timeline

• Start date: 2020-03-16
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-07-17
• Last updated: 2020-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study