NCT01936259

Comprehensive Shoulder System Nano IDE

A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).

Detailed description

The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer): 1. American Shoulder and Elbow Surgeons (ASES) Score 2. Single Assessment Numeric Evaluation (SANE) 3. Constant Score 4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence 5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.

Conditions

• Joint Disease

Interventions

Type	Name	Description
DEVICE	Mini Stem	The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
DEVICE	Nano	The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-11-21
• Completion: 2019-09-27
• First posted: 2013-09-06
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study