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

NCT ID: NCT01122498

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-04-30

Brief 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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

BMP-655/ACS+Standard of care or Standard of care

Intervention Type: BIOLOGICAL

BMP-655/ACS 0.015mg/mL

2

Group Type: EXPERIMENTAL

BMP-655/ACS+Standard of care or Standard of care

Intervention Type: BIOLOGICAL

BMP-655/ACS 0.05mg/mL

3

Group Type: EXPERIMENTAL

BMP-655/ACS+Standard of care or Standard of care

Intervention Type: BIOLOGICAL

BMP-655/ACS 0.15mg/mL or 0.025mg/mL

Interventions

BMP-655/ACS+Standard of care or Standard of care

BMP-655/ACS 0.015mg/mL

Intervention Type: BIOLOGICAL

BMP-655/ACS+Standard of care or Standard of care

BMP-655/ACS 0.05mg/mL

Intervention Type: BIOLOGICAL

BMP-655/ACS+Standard of care or Standard of care

BMP-655/ACS 0.15mg/mL or 0.025mg/mL

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Japanese male subjects and surgically sterile or postmenopausal Japanese female subjects between the ages of 25 and 75 years.
• without tears of the subscapularis or labral pathology requiring surgical repair, as estimated on closed magnetic resonance imaging (MRI) within 3 months before surgery.
• In the shoulder under study, subjects should be able to achieve a passive range of motion (ROM), which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of passive ROM in external rotation. In the contralateral shoulder, subjects should be able to achieve active ROM, which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of active ROM in external rotation.

Exclusion Criteria

• Subjects who have had previous surgical intervention to the shoulder joint under study (eg, shoulder arthroscopy, acromioplasty, previous RCR, fracture). Subjects with stage 3 or 4 fatty infiltration (according to the Goutallier grading scale) of their RC muscles on MRI taken within 3 months prior to surgical repair or subjects with moderate or severe degenerative glenohumeral arthritis (according to the Samilson and Prieto arthrosis grading scale ), avascular necrosis, calcific tendonitis, chondrocalcinosis, hypertrophic osteoarthropathy, or Paget disease of the shoulder under study or any bone abnormalities (eg, HO, previous fracture) as confirmed on a radiograph within 3 months prior to surgical repair.
• Subjects with rheumatologic conditions (eg, rheumatoid arthritis, ankylosing spondylitis) affecting the shoulder joints, or autoimmune disorders. Subjects treated with more than 3 corticosteroid injections in the shoulder under study within 1 year prior to planned surgery or subjects treated with any corticosteroid injection in the shoulder under study within 3 months prior to planned surgery or subjects currently receiving oral corticosteroids or taking them within the past 3 months.
• Subjects who are either unwilling or unable (eg, because of claustrophobia or the presence of an automatic cardioverter defibrillator) to undergo examination with closed MRI. Subjects with any other major illness/condition that will substantially increase the risk associated with the subject's participation in and completion of the study.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 28932752 (View on PubMed)

Other Identifiers

B1861003

Identifier Type: -

Identifier Source: secondary_id

3202V1-1003

Identifier Type: -

Identifier Source: org_study_id