This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Use of OP-1 Putty in Uninstrumented posterolateral fusion
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Royal Oak, Michigan, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
Time frame: 6 weeks; 3, 6, 9, 12, and 24 months
Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).
Time frame: 6 weeks; 3, 6, 9, 12, and 24 months
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Philadelphia, Pennsylvania, United States