search
Back to results

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

Primary Purpose

Degenerative Disc Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P-15L Bone Graft
Local autologous bone in a TLIF with Instrumentation
Sponsored by
CeraPedics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham
  • Glendale Adventist Medical Center
  • Keck School of Medicine USC
  • UC Irvine Medical Center
  • UC Davis Spine Center
  • Cedars-Sinai
  • Center for Spine and Orthopedics
  • UConn Health
  • St. Francis Hospital and Medical Center
  • University of South Florida
  • Florida Orthopaedic Institute
  • Northwestern University
  • Rush University Medical Center
  • Carle Foundation Hospital
  • Indiana Spine Group
  • OrthoIndy
  • Norton Leatherman Spine Center
  • Orthopaedic Institute of Western Kentucky
  • University of Michigan
  • University Of Buffalo
  • The Orthopedic Center at Mount Sinai West
  • SUNY Upstate Medical Center
  • Duke University Medical Center
  • University of Cincinnati
  • Cleveland Clinic
  • Rothman Institute
  • Thomas Jefferson University
  • Allegheny Health Network
  • University of Pittsburgh Medical Canter
  • Austin Neurosurgeons
  • Texas Back Institute
  • University of Texas Health Science Center at San Antonio
  • University of Virginia
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

P-15L Bone Graft

Local autologous bone

Arm Description

The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF

The active control group will be treated with local autologous bone in an instrumented TLIF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2018
Last Updated
August 28, 2023
Sponsor
CeraPedics, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT03438747
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CeraPedics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P-15L Bone Graft
Arm Type
Experimental
Arm Description
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
Arm Title
Local autologous bone
Arm Type
Active Comparator
Arm Description
The active control group will be treated with local autologous bone in an instrumented TLIF
Intervention Type
Device
Intervention Name(s)
P-15L Bone Graft
Intervention Description
The investigational group will be treated with P-15L in an instrumented TLIF
Intervention Type
Other
Intervention Name(s)
Local autologous bone in a TLIF with Instrumentation
Intervention Description
The active control group will be treated local autologous bone in an instrumented TLIF
Primary Outcome Measure Information:
Title
Secondary surgical intervention
Description
No index level secondary surgical intervention
Time Frame
24 Months
Title
Fusion
Description
Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Time Frame
24 Months
Title
Oswestry Disability Index (ODI)
Description
At least 15-point improvement in Oswestry Disability Index (ODI)
Time Frame
24 Months
Title
Neurological deficit
Description
No new or worsening, persistent neurological deficit
Time Frame
24 Months
Title
No serious device-related adverse event
Description
No serious device-related adverse event
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Keck School of Medicine USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Spine Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Cedars-Sinai
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Center for Spine and Orthopedics
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
St. Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
Norton Leatherman Spine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Orthopaedic Institute of Western Kentucky
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University Of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
The Orthopedic Center at Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Canter
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Austin Neurosurgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
73509
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs