Degenerative Disc Disease
Conditions
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.
Interventions
DEVICEP-15L Bone Graft
The investigational group will be treated with P-15L in an instrumented TLIF
OTHERLocal autologous bone in a TLIF with Instrumentation
The active control group will be treated local autologous bone in an instrumented TLIF
Sponsors
CeraPedics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No serious device-related adverse event | 72 Months | No serious device-related adverse event |
| 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 |
| Secondary surgical intervention | 72 Months | No index level secondary surgical intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed