Rotator Cuff Tear
Conditions
Keywords
rotator cuff tear repair, open surgical technique, safety
Brief summary
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
Detailed description
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions. Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
Interventions
BIOLOGICALBMP-655/ACS or Standard of Care
Decision was made by Legal to withhold this information
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Investigator Questionnaire | 1 year |
Countries
Germany, Netherlands
Outcome results
None listed