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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03438747
• Other study ID #: CP-1006
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: February 28, 2028

Study information

• Verified date: August 2023
• Source: CeraPedics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT03502057

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: February 28, 2028
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• P-15L Bone Graft
The investigational group will be treated with P-15L 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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Austin Neurosurgeons	Austin	Texas
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	University Of Buffalo	Buffalo	New York
United States	Indiana Spine Group	Carmel	Indiana
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	UConn Health	Farmington	Connecticut
United States	Glendale Adventist Medical Center	Glendale	California
United States	St. Francis Hospital and Medical Center	Hartford	Connecticut
United States	OrthoIndy	Indianapolis	Indiana
United States	Keck School of Medicine USC	Los Angeles	California
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	The Orthopedic Center at Mount Sinai West	New York	New York
United States	UC Irvine Medical Center	Orange	California
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Canter	Pittsburgh	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	UC Davis Spine Center	Sacramento	California
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Florida Orthopaedic Institute	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Center for Spine and Orthopedics	Thornton	Colorado
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Cedars-Sinai	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
CeraPedics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary surgical intervention	No index level secondary surgical intervention	24 Months
Primary	Fusion	Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)	24 Months
Primary	Oswestry Disability Index (ODI)	At least 15-point improvement in Oswestry Disability Index (ODI)	24 Months
Primary	Neurological deficit	No new or worsening, persistent neurological deficit	24 Months
Primary	No serious device-related adverse event	No serious device-related adverse event	24 Months