Degenerative Spinal Conditions Clinical Trial
Official title:
A Pre-market, Open-label, Single-arm Study to Evaluate b.Bone for Posterolateral Fusion Treatment of Degenerative Thoracolumbar, Lumbar or Lumbosacral Spinal Disease (b.Spine Clinical Trial).
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety. Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.
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