Clinical trial NCT03438747: P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Official title: An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Lead sponsor: CeraPedics, Inc
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 290
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria (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;

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 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

Primary outcomes:
measure: Secondary surgical intervention
timeFrame: 24 Months
measure: Fusion
timeFrame: 24 Months
measure: Oswestry Disability Index (ODI)
timeFrame: 24 Months
measure: Neurological deficit
timeFrame: 24 Months
measure: No serious device-related adverse event
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine USC
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai
state: California
city: Thornton
country: United States
facility: Center for Spine and Orthopedics
state: Colorado
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Buffalo
country: United States
facility: University Of Buffalo
state: New York
city: New York
country: United States
facility: The Orthopedic Center at Mount Sinai West
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Canter
state: Pennsylvania
city: Austin
country: United States
facility: Austin Neurosurgeons
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: