Status:
ACTIVE_NOT_RECRUITING
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Lead Sponsor:
CeraPedics, Inc
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
22-80 years
Phase:
NA
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 (c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2028
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT03438747
Start Date
April 24 2018
End Date
February 28 2028
Last Update
October 6 2025
Active Locations (34)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Glendale Adventist Medical Center
Glendale, California, United States, 91206
3
Keck School of Medicine USC
Los Angeles, California, United States, 90033
4
UC Irvine Medical Center
Orange, California, United States, 92868