Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2016-09-09

Brief Summary

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Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.

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Detailed Description

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Conditions

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Total Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

blinded to purpose of study and to randomization

Study Groups

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glenosphere 42

patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

Group Type ACTIVE_COMPARATOR

reverse shoulder arthroplasty

Intervention Type DEVICE

prosthesis implantation

glenosphere 38 ECC

patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch

Group Type ACTIVE_COMPARATOR