Columbia Shoulder Study (CSS)
Completed
Conditions studied: Osteoarthritis of Glenohumeral Joint
In brief
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.
Key facts
- Study ID
- NCT01488006
- Run by
- Columbia University
- People needed
- 207
- Starts
- 2001-04-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2015-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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