Status:
COMPLETED
Columbia Shoulder Study (CSS)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Osteoarthritis of Glenohumeral Joint
Eligibility:
All Genders
18+ years
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 f...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT01488006
Start Date
April 1 2001
End Date
November 1 2012
Last Update
July 9 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032