NCT03438747

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: CeraPedics, Inc · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	P-15L Bone Graft	The investigational group will be treated with P-15L in an instrumented TLIF
OTHER	Local autologous bone in a TLIF with Instrumentation	The active control group will be treated local autologous bone in an instrumented TLIF

Timeline

• Start date: 2018-04-24
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2018-02-20
• Last updated: 2025-10-06

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated device study