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

Not Applicable

Active, not recruiting

• Conditions: Degenerative Disc Disease

• Registration Number: NCT03438747
• Lead Sponsor: CeraPedics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-20
• Study Start: 2018-04-24
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-06
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (34)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

Keck School of Medicine USC; 🇺🇸 Los Angeles, California, United States

UC Irvine Medical Center; 🇺🇸 Orange, California, United States

UC Davis Spine Center; 🇺🇸 Sacramento, California, United States

Cedars-Sinai; 🇺🇸 West Hollywood, California, United States

Center for Spine and Orthopedics; 🇺🇸 Thornton, Colorado, United States

UConn Health; 🇺🇸 Farmington, Connecticut, United States

St. Francis Hospital and Medical Center; 🇺🇸 Hartford, Connecticut, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

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