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

Use our guide to learn which trials are right for you!

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
22
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
13020 N Telecom Pkwy
Tampa, Florida 33637
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Burlington, Massachusetts 01805
?
mi
from
Burlington, MA
Click here to add this to my saved trials
Carmel, Indiana 46032
?
mi
from
Carmel, IN
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hartford, Connecticut 06105
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Indianapolis, Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Los Angeles, California 90008
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New Britain, Connecticut 06050
?
mi
from
New Britain, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Royal Oak, Michigan 01803
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Thornton, Colorado 80229
?
mi
from
Thornton, CO
Click here to add this to my saved trials
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials