Columbia Shoulder Study (CSS)
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.
Osteoarthritis of Glenohumeral Joint
Device: Bigliani/Flatow Shoulder System
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||5- Year Follow-up in Total Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: A Prospective Multicenter Study|
- Preoperative Radiographic Measurements of Standard Glenohumeral Relationships [ Time Frame: Up to 16 weeks prior to date of surgery ] [ Designated as safety issue: No ]
- Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays) [ Time Frame: Up to 5 years postoperatively ] [ Designated as safety issue: No ]Measurements include acromiohumeral interval, head to tuberosity distance, coracoid to glenohumeral joint distance, coracoid to tuberosity distance, humeral stem position (valgus/varus), humeral congruity and subluxation, glenoid comp version.
- Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening [ Time Frame: Up to 5 year postoperatively ] [ Designated as safety issue: No ]glenoid and humeral component lucency
- Change in Score on Short-Form 36 (SF-36) [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]Mental component score, physical component score, mental health, physical function, role emotional, role physical, social function, vitality, bodily pain and general health
- Change in Score on EuroQOL (EQ-5D) [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]Total index, visual analog scale, mobility, anxiety/depression, pain/discomfort, self-care, and usual activities.
- Change in ASES (American Shoulder and Elbow Surgeons) Score [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]
- Change in Total Score on Simple Shoulder Test (SST) [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]Total score.
- Change in Constant Score [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]
- Change in Range of Motion [ Time Frame: Up to 5 years postoperatively. ] [ Designated as safety issue: No ]Active and passive external rotation at 90 degrees and at side, active and passive forward elevation, active and passive abduction, active and passive internal rotation
|Study Start Date:||April 2001|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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).
Device: Bigliani/Flatow Shoulder System
Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488006
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||William N Levine, MD||Columbia University|