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Comprehensive Segmental Revision System

2017-09-04 22:02:11 | BioPortfolio

Summary

Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.

Description

The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.

The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).

Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.

The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least five (5) years from the time of surgery.

Study Design

Conditions

Degenerative Disease

Intervention

Comprehensive SRS Replacement

Location

Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen
Copenhagen
Wales
Denmark
NP20 2UB

Status

Recruiting

Source

Zimmer Biomet

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-04T22:02:11-0400

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Medical and Biotech [MESH] Definitions

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