Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Primary	Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Revision	Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Continued Access	Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.

Participant Flow:   Overall Study

	Primary	Revision	Continued Access
STARTED	141	141	234
COMPLETED	75	71	131
NOT COMPLETED	66	70	103
Death	12	6	13
Revision of Device	12	23	14
Physician Decision	1	0	0
Withdrawal by Subject	1	7	4
Lost to Follow-up	40	34	72

Reporting Groups

	Description
Primary	Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
Revision	Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
Continued Access	Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.

Baseline Measures

	Primary	Revision	Continued Access	Total
Number of Participants   [units: participants]	141	141	234	516
Age   [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	30	52	57	139
>=65 years	111	89	177	377
Age   [units: years] Mean ± Standard Deviation	71.9  ± 9.5	67.4  ± 11.6	71.2  ± 9.2	70.4  ± 10.1
Gender   [units: participants]
Female	87	97	136	320
Male	54	44	98	196
Region of Enrollment   [units: participants]
United States	141	141	234	516
Operative Shoulder   [units: participants]
Right	87	83	146	316
Left	54	58	88	200

1.  Primary:

American Shoulder and Elbow Surgeons Shoulder Score   [ Time Frame: 2-year ]

2.  Primary:

Average Range of Motion   [ Time Frame: 2-year ]

3.  Primary:

Subject Satisfaction With Surgery   [ Time Frame: 2-year ]

4.  Primary:

Have Surgery Again?   [ Time Frame: 2-year ]

5.  Primary:

Neer's "Limited Goals"   [ Time Frame: 2-year ]

6.  Primary:

Radiographic Failures   [ Time Frame: Post-operative, 3-month, 6-month, 1-year, 2-year ]

7.  Primary:

Safety Assessment   [ Time Frame: 2-year ]