A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

Summary

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.

Timeline

Start

2010-06

Primary completion

2012-04

Completion

2012-04

Publications

• Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.

Drugs

Indications