Last updated on June 2020

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation


Brief description of study

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Clinical Study Identifier: NCT03438747

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Norton Leatherman Spine Center

Louisville, KY United States
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