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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
Sponsor:
Information provided by (Responsible Party):
CeraPedics, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: P-15L Bone Graft Other: Local autologous bone in a TLIF with Instrumentation Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arms and Interventions
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Arm Intervention/treatment
Experimental: P-15L Bone Graft
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
 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
 Other: Local autologous bone in a TLIF with Instrumentation
The active control group will be treated local autologous bone in an instrumented TLIF


Outcome Measures
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Primary Outcome Measures :
  1. Secondary surgical intervention [ Time Frame: 24 Months ]
    No index level secondary surgical intervention

  2. Fusion [ Time Frame: 24 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: 24 Months ]
    At least 15-point improvement in Oswestry Disability Index (ODI)

  4. Neurological deficit [ Time Frame: 24 Months ]
    No new or worsening, persistent neurological deficit

  5. No serious device-related adverse event [ Time Frame: 24 Months ]
    No serious device-related adverse event


Eligibility Criteria
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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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jennifer Dugan 610-454-7200 cp1006@emergentclinical.com

Locations
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Sponsors and Collaborators
CeraPedics, Inc
More Information
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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

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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
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases