Columbia Shoulder Study (CSS)

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01488006
First received: November 29, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

This Multicenter 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
Glenohumeral Osteoarthritis
Device: Bigliani/Flatow Shoulder System
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Bigliani/Flatow Shoulder System
    Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01488006

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

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01488006     History of Changes
Other Study ID Numbers: AAAA5360-1
Study First Received: November 29, 2011
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014