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Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Berlin, , 10117 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rotator Cuff Tear
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00936559
Pfizer
Terminated
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair

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[email protected]

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