CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 258 enrolled
Drug / intervention
Mini Stem +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01936259
NCT01936259N/ACompleted
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A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

Zimmer Biomet·interventional·Posted Sep 6, 2013·Updated Jan 13, 2020

In Brief

A clinical study evaluating Mini Stem and Nano for Joint Disease. Completed, enrolled 258 participants across 12 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJoint Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 6, 2013
Enrollment StartAug 1, 2013
Primary CompletionNov 21, 2018
Study CompletionSep 27, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.8 years ago

Interventions

Mini Stemdevice

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.

Nanodevice

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.