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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03438747
Study type Interventional
Source CeraPedics, Inc
Contact
Status Active, not recruiting
Phase N/A
Start date April 24, 2018
Completion date February 28, 2028
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