Comprehensive Nano

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

ACTIVE_NOT_RECRUITING

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-30

Study Completion Date

2030-07-31

Brief Summary

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This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

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Detailed Description

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The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.

This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.

Conditions

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Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision Correction of Functional Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anatomic

Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.

Intervention Type DEVICE

Patients requiring the Comprehensive Nano shoulder system.

Reverse

Patients who have received the Reverse version of the Comprehensive Nano.

Comprehensive Nano

Intervention Type DEVICE

Patients requiring the Comprehensive Nano shoulder system.

Interventions

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