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

Purpose

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

  • Degenerative Disc Disease

Eligibility

Eligible Ages
Between 22 Years and 80 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Active, not recruiting
Sponsor
CeraPedics, Inc

Study Contact