Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438747
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
CeraPedics, Inc

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 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 : September 30, 2021
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


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
Layout table for location contacts
Contact: Jennifer Dugan 610-454-7200 cp1006@emergentclinical.com

  Show 22 Study Locations
Sponsors and Collaborators
CeraPedics, Inc

Layout table for additonal information
Responsible Party: CeraPedics, Inc
ClinicalTrials.gov Identifier: NCT03438747     History of Changes
Obsolete Identifiers: NCT03502057
Other Study ID Numbers: CP-1006
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases