Summary

Eligibility
for people ages 22-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Degenerative Disc Disease Intervertebral Disc Degeneration P-15L Bone Graft Local autologous bone in a TLIF with Instrumentation Local autologous bone

Eligibility

You can join if…

Open to people ages 22-80

(abbreviated):

Skeletally mature adults between 22 and 80 years old (inclusive);

Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;

Involved disc(s) between L2 and S1;

You CAN'T join if...

(abbreviated):

Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;

Active malignancy;

Nondiscogenic source of symptoms (e.g. tumor, etc.);

Multiple level symptomatic degenerative disc disease where more than one level requires fusion;

Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;

More than one level to be fused

Locations

  • UC Davis Spine Center accepting new patients
    Sacramento California 95816 United States
  • Glendale Adventist Medical Center accepting new patients
    Glendale California 91206 United States
  • Cedars-Sinai accepting new patients
    West Hollywood California 90069 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CeraPedics, Inc
Links
Sign up for this study
ID
NCT03438747
Study Type
Interventional
Last Updated