In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Neuro Degenerative / Lumbar Spine Fusion
Title
HUD study for patients with posteriolateral lumbar spinal fusion (Neuro Degenerative / Lumbar Spine Fusion)
Description
This is not a research study. OP-1 Putty is an FDA-approved device under the Humanitarian Use Device (HUD) regulations.
IRB Number
Pro2063
Inclusion/Notes
INCLUSION:
OP-1 Putty is approved as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.
EXCLUSION:
The use of OP-1 Putty is contraindicated in the following:
OP-1 Putty should not be used to treat patients who have a known hypersensitivity to the active substance or to collagen.
OP-1 Putty should not be applied at or near the vicinity of a resected tumor or in patients with a history of malignancy.
OP-1 Putty should not be administered to patients who are skeletally immature (<18 years of age or no radiographic evidence of closure of epiphyses).
OP-1 Putty should not be administered to pregnant women.
