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NCT Number: NCT03438747

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P-15L Bone Graft

Device

The investigational group will be treated with P-15L in an instrumented TLIF

Local autologous bone in a TLIF with Instrumentation

Other

The active control group will be treated local autologous bone in an instrumented TLIF

Primary outcomes

  1. Secondary surgical intervention

    Time frame: 72 Months

    No index level secondary surgical intervention

  2. Fusion

    Time frame: 72 Months

    Achievement of fusion (Fusion is defined as evidence of bridging trabecular bone between the vertebral bodies by CT scan)

  3. Oswestry Disability Index (ODI)

    Time frame: 72 Months

    At least 15-point improvement in Oswestry Disability Index (ODI)

  4. Neurological deficit

    Time frame: 72 Months

    No new or worsening, persistent neurological deficit

  5. No serious device-related adverse event

    Time frame: 72 Months

    No serious device-related adverse event

Secondary outcomes

  1. Time to Fusion

    Time frame: 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.

  2. VAS pain scores

    Time frame: 72 months

    Pain at back and pain at legs will be measured by a 100-point Visual Analog Scale (VAS)

  3. Physical Function and Mental Health Composite Scores

    Time frame: 72 months

    SF-12 and changes over time

Sponsors and collaborators

Lead sponsor

CeraPedics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2018
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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