- Male subjects and surgically sterile or postmenopausal female subjects between the
ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI
within 3 months before surgery.
- Subjects who have had previous surgical intervention to the shoulder joint under study
or additional injury requiring surgical repair or a history of shoulder dislocation in
the affected shoulder or physical examination findings of instability in either
shoulder
- Subjects who are unable to complete functional evaluations because of any other
concurrent injuries or impairment in either the arm
- Subjects identified with specific fatty infiltration of their RC muscles on MRI taken
within 3 months prior to surgical repair
- Subjects with moderate or severe degenerative arthritis of the shoulder under study or
any bone abnormalities as confirmed on a radiograph
- Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune
disorders, treated with more than 3 corticosteroid injections in the shoulder under
study within 1 year of planned surgery, any recent corticosteroid injection in the
shoulder or currently receiving oral corticosteroids
- Subjects who are either unwilling or unable to undergo examination with closed MRI.