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

Study Overview
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Brief Summary
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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.

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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: P-15L Bone Graft
* Other: Local autologous bone in a TLIF with Instrumentation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-15L Bone Graft<br>The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF | Device: P-15L Bone Graft<br>* The investigational group will be treated with P-15L in an instrumented TLIF<br>|
| Active Comparator: Local autologous bone<br>The active control group will be treated with local autologous bone in an instrumented TLIF | Other: Local autologous bone in a TLIF with Instrumentation<br>* The active control group will be treated local autologous bone in an instrumented TLIF<br>|

What is the study measuring?
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Primary Outcome Measures

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