Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
BMP-655/ACS 0.015mg/mL
BMP-655/ACS 0.05mg/mL
BMP-655/ACS 0.15mg/mL or 0.025mg/mL
Pfizer Investigational Site
Chikushino-shi, Fukuoka, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Pfizer Investigational Site
Kumamoto, Kumamoto, Japan
Pfizer Investigational Site
Toyonaka, Osaka, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Kanagawa, Japan
Pfizer Investigational Site
Kumamoto, Japan
Pfizer Investigational Site
Nagano, Japan
Assess the safety and tolerability of 3 concentrations of BMP-655/ACS in Japanese subjects with full-thickness RCTs treated by means of an open surgical repair.
Time frame: 12, 26 and 52 weeks
Assess the feasibility of implanting BMP-655/ACS through an open surgical procedure in Japanese subjects and detect circulating levels of BMP-655 in the blood of Japanese subjects.
Time frame: 52 weeks
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