Columbia Shoulder Study (CSS)

NCT ID: NCT01488006

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2012-11-30

Brief 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.

Detailed Description

Over the last two decades, total shoulder joint replacement - or arthroplasty - has become a commonly performed procedure for the treatment of painful arthritis of the shoulder, and numerous studies have demonstrated its success. During this time, much has been learned about the efficacy, as well as the complications, of the procedure, and since its introduction in the 1950's, shoulder arthroplasty has undergone an evolution in design. The value of such innovations has not yet been determined and will depend on the results of long term follow-up studies. The purpose of this study is to provide follow-up information and design modification directives.

Conditions

Osteoarthritis of Glenohumeral Joint

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bigliani/Flatow Shoulder System

Other than the Bigliani/Flatow device, there will be no difference in treatment between those patients undergoing arthroplasty with the Bigliani / Flatow prosthesis and those who previously received other prosthesis. APatients who decide to participate in the study will complete various forms prior to surgery (The Informed Consent, Contact Information Form, Demographics Module, and standard outcomes forms such as American Shoulder and Elbow Surgeon Score form, Constant's Score form, and the Simple Shoulder Test, EuroQOL and SF-36). The patient will also complete forms postoperatively at 3-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year intervals (American Shoulder and Elbow Surgeon Score form, Constant's Score form, Simple Shoulder Test, EuroQOL and SF-36).

Bigliani/Flatow Shoulder System

Intervention Type: DEVICE

Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis

Interventions

Bigliani/Flatow Shoulder System

Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient must be 18 years of age or over.
• Patient must have signed The Informed Consent and Release of Medical Information forms.
• The patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
• Patient needs a total shoulder arthroplasty (humeral head and glenoid).
• Patient has a diagnosis of primary osteoarthritis.

Exclusion Criteria

• Obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
• Class IV or higher anesthetic risk.
• Patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
• Patient has had a shoulder fracture.
• Patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
• The patients has a massive rotator cuff tear (rupture >3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William N Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAA5360

Identifier Type: -

Identifier Source: org_study_id