Columbia Shoulder Study (CSS) (CSS)
|ClinicalTrials.gov Identifier: NCT01488006|
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Glenohumeral Joint||Device: Bigliani/Flatow Shoulder System||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||207 participants|
|Official Title:||5- Year Follow-up in Total Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: A Prospective Multicenter Study|
|Study Start Date :||April 2001|
|Primary Completion Date :||October 2009|
|Study Completion Date :||November 2012|
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
- Preoperative Radiographic Measurements of Standard Glenohumeral Relationships [ Time Frame: Up to 16 weeks prior to date of surgery ]
- Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays) [ Time Frame: Up to 5 years postoperatively ]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 ]glenoid and humeral component lucency
- Change in Score on Short-Form 36 (SF-36) [ Time Frame: Up to 5 years postoperatively. ]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. ]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. ]
- Change in Total Score on Simple Shoulder Test (SST) [ Time Frame: Up to 5 years postoperatively. ]Total score.
- Change in Constant Score [ Time Frame: Up to 5 years postoperatively. ]
- Change in Range of Motion [ Time Frame: Up to 5 years postoperatively. ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488006
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||William N Levine, MD||Columbia University|