P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neurological deficit 24 Months No new or worsening, persistent neurological deficit
Oswestry Disability Index (ODI) 24 Months At least 15-point improvement in Oswestry Disability Index (ODI)
Fusion 24 Months Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
Secondary surgical intervention 24 Months No index level secondary surgical intervention
No serious device-related adverse event 24 Months No serious device-related adverse event
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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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
Scroll for more (24 remaining)The University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States