Columbia Shoulder Study (CSS)

This study has been completed.
Zimmer, Inc.
Information provided by (Responsible Party):
Columbia University Identifier:
First received: November 29, 2011
Last updated: July 7, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Osteoarthritis of Glenohumeral Joint
Device: Bigliani/Flatow Shoulder System
Phase 4

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 207
Study Start Date: April 2001
Study Completion Date: November 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be recruited when the decision to undergo shoulder arthroplasty is made. The surgeon will confirm that the subject is appropriate for inclusion in the study. The surgeon will confirm that the subject is appropriate for inclusion in the study.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01488006

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Zimmer, Inc.
Principal Investigator: William N Levine, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University Identifier: NCT01488006     History of Changes
Other Study ID Numbers: AAAA5360
Study First Received: November 29, 2011
Last Updated: July 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Primary Glenohumeral Osteoarthritis
Total shoulder arthroplasty
Total shoulder replacement
Multicenter study

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 27, 2015