Comprehensive Shoulder System Nano IDE

NACompletedINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

November 21, 2018

Study Completion Date

September 27, 2019

Conditions
Joint Disease
Interventions
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.

Trial Locations (12)

14214

University of Buffalo, Buffalo

21204

Towson Orthopaedic Associates, Towson

22903

University of Virginia, Charlottesville

23114

Bon Secours St. Francis Medical Center, Midlothian

33308

Holy Cross Hospital, Fort Lauderdale

38138

Campbell Clinic Orthopaedics, Germantown

43054

Joint Implant Surgeons, New Albany

46825

Ortho NorthEast, Fort Wayne

48073

William Beaumont Hospital, Royal Oak

55905

Mayo Clinic, Rochester

71105

Orthopedic Clinic, Shreveport

85255

Arizona Institute for Sports, Knees, and Shoulders, Scottsdale

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Zimmer Biomet

INDUSTRY

NCT01936259 - Comprehensive Shoulder System Nano IDE | Biotech Hunter | Biotech Hunter