The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.
A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
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Santa Monica, California, United States
Unnamed facility
Stanford, California, United States
Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations
Time frame: 3, 6, 12, 24 months
The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use
Time frame: 3, 6, 12, 24 months
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Denver, Colorado, United States
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Newark, Delaware, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Kalamazoo, Michigan, United States
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Southfield, Michigan, United States
...and 14 more locations