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Columbia Shoulder Study (CSS)

NCT01488006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 207

Last updated 2015-07-09

No results posted yet for this study

Summary

This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons as to features of the implants, instruments, and techniques which may be further improved. In this study, the investigators hypothesize that this prosthetic device will significantly improve long-term patient-based outcomes, functional status and quality of life.

Conditions

  • Osteoarthritis of Glenohumeral Joint

Interventions

DEVICE

Bigliani/Flatow Shoulder System

Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis

Sponsors & Collaborators

Principal Investigators

  • William N Levine, MD · Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2009-10-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488006 on ClinicalTrials.gov