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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: P-15L Bone Graft; Other: Local autologous bone in a TLIF with Instrumentation

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine USC
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
    • Sacramento, California, United States, 95816
      • UC Davis Spine Center
    • West Hollywood, California, United States, 90069
      • Cedars-Sinai
  • Colorado
    • Thornton, Colorado, United States, 80229
      • Center for Spine and Orthopedics
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health
    • Hartford, Connecticut, United States, 06105
      • St. Francis Hospital and Medical Center
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute
    • Tampa, Florida, United States, 33606
      • University Of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
    • Indianapolis, Indiana, United States, 46278
      • OrthoIndy
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Leatherman Spine Center
    • Paducah, Kentucky, United States, 42001
      • Orthopaedic Institute of Western Kentucky
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • New York, New York, United States, 10029
      • The Orthopedic Center at Mount Sinai West
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Canter
  • Texas
    • Austin, Texas, United States, 78746
      • Austin Neurosurgeons
    • Plano, Texas, United States, 73509
      • Texas Back Institute
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P-15L Bone Graft; The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF	Device: P-15L Bone Graft; The investigational group will be treated with P-15L in an instrumented TLIF
Active Comparator: Local autologous bone; The active control group will be treated with local autologous bone in an instrumented TLIF	Other: Local autologous bone in a TLIF with Instrumentation; The active control group will be treated local autologous bone in an instrumented TLIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary surgical intervention	No index level secondary surgical intervention	72 Months
Fusion	Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)	72 Months
Oswestry Disability Index (ODI)	At least 15-point improvement in Oswestry Disability Index (ODI)	72 Months
Neurological deficit	No new or worsening, persistent neurological deficit	72 Months
No serious device-related adverse event	No serious device-related adverse event	72 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Fusion	The distribution of visits (month 6, 12, or 24) at which fusion is confirmed is the same for the investigational and control devices.	24 months
VAS pain scores	Pain at back and pain at legs will be measured by a 100-point Visual Analog Scale (VAS)	72 months
Physical Function and Mental Health Composite Scores	SF-12 and changes over time	72 months

Collaborators and Investigators

• Sponsor: CeraPedics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CP-1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No