Columbia Shoulder Study (CSS)

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.

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.