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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 : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
CeraPedics, Inc

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
Official Title  ICMJE An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE
  • Device: P-15L Bone Graft
    The investigational group will be treated with P-15L 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
Study Arms  ICMJE
  • Experimental: P-15L Bone Graft
    The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
    Intervention: Device: P-15L Bone Graft
  • Active Comparator: Local autologous bone
    The active control group will be treated with local autologous bone in an instrumented TLIF
    Intervention: Other: Local autologous bone in a TLIF with Instrumentation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
270
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE November 30, 2027
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Dugan 610-454-7200 cp1006@emergentclinical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438747
Other Study ID Numbers  ICMJE CP-1006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CeraPedics, Inc
Study Sponsor  ICMJE CeraPedics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CeraPedics, Inc
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP