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

Condition(s) studied

Investigational drug(s) / intervention(s)

P-15L Bone Graft: The investigational group will be treated with P-15L in an instrumented TLIF

Local autologous bone in a TLIF with Instrumentation: The active control group will be treated local autologous bone in an instrumented TLIF

Study summary

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.

Eligibility

Primary outcome measure(s)

• Secondary surgical intervention — 72 Months
  No index level secondary surgical intervention
• Fusion — 72 Months
  Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
• Oswestry Disability Index (ODI) — 72 Months
  At least 15-point improvement in Oswestry Disability Index (ODI)
• Neurological deficit — 72 Months
  No new or worsening, persistent neurological deficit
• No serious device-related adverse event — 72 Months
  No serious device-related adverse event

Trial sites (34)

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