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

Status:	Recruiting
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	22 - 75
Updated:	2/6/2019
Start Date:	April 24, 2018
End Date:	September 30, 2025
Contact:	Roger White
Email:	rwhite@cerapedics.com
Phone:	303-550-2451

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

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.

Inclusion Criteria (abbreviated):

Skeletally mature adults between 22 and 75 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;

Exclusion Criteria (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;

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

More than one level to be operated;

We found this trial at

sites

Florida Orthopaedic Institute

13020 N Telecom Pkwy
Tampa, Florida 33637

from

Tampa, FL