The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
BRCs will be administered during spine fusion surgery
The primary objective is to confirm that the TRC product, when used as a bone graft, is safe for use in posterolateral lumbar spinal fusion surgery, on the basis of defined radiographic evidence of bone fusion.
Time frame: Throughout duration of study
To assess the relative efficacy of TRC graft compared to autologous vertebral bone graft based on the frequency and extent of callus or bone bridging between the adjacent decorticated vertebral processes on each side of the vertebrae.
Time frame: Imaged by CT at 6 months after surgery
To assess surgeon's evaluation of radiographic healing at the site of surgery based on flexion and extension radiographs, as well as 2AP and lateral radiographs, and of clinical resolution
Time frame: Baseline, Month 6 and Month 12
To assess reduction in pain scores at site of back surgery
Time frame: First 3 months post-treatment
To assess use of prescription and non-prescription pain control and other drugs in treatment patients as compared to control patients
Time frame: Throughout duration of study
To assess restoration of function for return to activities of normal daily living
Time frame: Month 6 and Month 12
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