A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
NCT01122498
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears | |||
Official Title ICMJE | A Phase 1, Randomized, Open-Label, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full-Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Repair | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Rotator Cuff Tear | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 23 | |||
Original Estimated Enrollment ICMJE | 42 | |||
Actual Study Completion Date ICMJE | April 2012 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 25 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01122498 | |||
Other Study ID Numbers ICMJE | 3202V1-1003 B1861003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |