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

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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
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...
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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...
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13020 N Telecom Pkwy
Tampa, Florida 33637
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Burlington, Massachusetts 01805
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Carmel, Indiana 46032
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303 East Superior Street
Chicago, Illinois 60611
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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...
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Hartford, Connecticut 06105
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Indianapolis, Indiana
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Los Angeles, California 90008
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Louisville, Kentucky 40202
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New Britain, Connecticut 06050
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Philadelphia, Pennsylvania 19107
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Pittsburgh, Pennsylvania 15213
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Royal Oak, Michigan 01803
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San Diego, California 92093
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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...
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Thornton, Colorado 80229
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Urbana, Illinois 61801
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