Degenerative Disc Disease Clinical Trial
Official title:
OsteoAdapt SP Feasibility Study A Prospective, Blinded, Controlled, Dose-Randomized Clinical Investigation of OsteoAdapt SP in Transforaminal Lumbar Interbody Fusion in Treatment of Symptomatic Degenerative Disease of The Lumbosacral Spine
The purpose of this clinical study is to assess the safety and effectiveness of the OsteoAdapt SP as a replacement for the autograft standard of care bone graft within the interbody cage, as well as identify the OsteoAdapt SP dose to be investigated in a future pivotal study.
This Feasibility Study is a prospective, blinded, controlled, dose-randomized, multicenter, investigational study to evaluate the safety and effectiveness of the OsteoAdapt SP in single-level TLIF procedures for the treatment of symptomatic degenerative diseases of the lumbosacral spine. Patients undergoing elective unilateral, single-level, single interbody cage TLIF who have had at least 6 months of conservative care, met the inclusion criteria and none of the exclusion criteria, and sign the patient informed consent will be screened for enrollment and treated consistent with current TLIF surgical standard of care except that the autograft bone graft component within the interbody cage will be replaced with OsteoAdapt SP. Patients will be randomized to receive OsteoAdapt SP at one of two available concentrations (0.8 mg/cc or 2 mg/cc) with ~ 25-26 patients in each group, or the control group consisting of another ~25-26 patients for a total of ~75-80 patients. Standard lottery randomization will be used with equal weight in each of the three groups. The investigational group will use the randomized concentration of OsteoAdapt SP within the interbody cage and placement of autograft anterior (or laterally within the disc space) to the cage if desired by the investigator. Control subjects will have autograft harvested from the local site and utilized both inside and anterior (or lateral) to the interbody cage with the option of banked mineralized frozen allograft to supplement if there is not enough local autograft available. ;
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