P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
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ClinicalTrials.gov Identifier: NCT03438747 |
Recruitment Status :
Recruiting
First Posted : February 20, 2018
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Degenerative Disc Disease | Device: P-15L Bone Graft Other: Local autologous bone in a TLIF with Instrumentation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 270 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation |
Actual Study Start Date : | April 24, 2018 |
Estimated Primary Completion Date : | November 30, 2021 |
Estimated Study Completion Date : | November 30, 2027 |

Arm | Intervention/treatment |
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Experimental: P-15L Bone Graft
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
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Device: P-15L Bone Graft
The investigational group will be treated with P-15L in an instrumented TLIF |
Active Comparator: Local autologous bone
The active control group will be treated with local autologous bone in an instrumented TLIF
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Other: Local autologous bone in a TLIF with Instrumentation
The active control group will be treated local autologous bone in an instrumented TLIF |
- Secondary surgical intervention [ Time Frame: 24 Months ]No index level secondary surgical intervention
- Fusion [ Time Frame: 24 Months ]Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)
- Oswestry Disability Index (ODI) [ Time Frame: 24 Months ]At least 15-point improvement in Oswestry Disability Index (ODI)
- Neurological deficit [ Time Frame: 24 Months ]No new or worsening, persistent neurological deficit
- No serious device-related adverse event [ Time Frame: 24 Months ]No serious device-related adverse event

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Ages Eligible for Study: | 22 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438747
Contact: Jennifer Dugan | 610-454-7200 | cp1006@emergentclinical.com |

Responsible Party: | CeraPedics, Inc |
ClinicalTrials.gov Identifier: | NCT03438747 |
Obsolete Identifiers: | NCT03502057 |
Other Study ID Numbers: |
CP-1006 |
First Posted: | February 20, 2018 Key Record Dates |
Last Update Posted: | October 8, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Intervertebral Disc Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases |