Clinical Trial: b.Spine Clinical Trial
Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Condition: Degenerative Spinal Conditions
Study Type: INTERVENTIONAL
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).
Brief Summary:
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…
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