P-15L Bone Graft Lumbar Fusion Clinical Trial

Degenerative Disc Disease Clinical Trial

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

Status Recruiting

Clinical Trial Summary

Study Design: Prospective, single-blinded, multi-center, randomized, controlled, pivotal study Study Objective: To evaluate if P-15L is not inferior in effectiveness and safety to local autologous bone (and allograft as extender where necessary) when applied in instrumented TLIF in subjects with Degenerative disc disease (DDD)

Study Endpoints:

Primary endpoint: Month 24 Composite Clinical Success (CCS):

• Achievement of fusion (Evidence of continuous trabecular bridging bone in the intervertebral space)

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

• No new or worsening, persistent neurological deficit

• No subsequent surgical intervention at the index level

Once fusion is radiographically confirmed, it will be assumed that fusion has occurred at all subsequent time points without the need to reconfirm fusion status at later time points.

Multiplicity Controlled Secondary endpoint:

• Visit at which fusion is confirmed.

Other Secondary endpoints:

• Visual Analog Scale (VAS) pain scores, changes over time, and achievement of a 20 mm improvement (Back, left leg, right leg);

• Physical Function and Mental Health Composite Scores (Short Form Health Survey SF-12 and changes over time).

Clinical Trial Description

Cerapedics currently markets a peptide-enhanced bone graft product, i-FACTOR putty, for use in cervical spine degenerative disk disease. i-FACTOR putty is a composite bone substitute material consisting of the P-15 peptide adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 is a synthetic, 15-amino acid peptide that mimics the cellbinding domain of Type I collagen and is able to signal a mechanical and biochemical communication pathway that ultimately results in new bone formation. The P-15 peptide enhances cell migration and induces osteoblast cell proliferation and differentiation. P-15 is specific to anchoring-dependent connective tissue mesenchymal cells, including osteogenic cells,and therefore does not induce bone formation in the absence of these cells. The receptor mediated anchorage of osteoblasts by P-15 initiates a number of signal transduction pathways that lead to the synthesis of growth factors, cytokines, and bone morphogenetic proteins.

A prospective, randomized, controlled, multi-center clinical trial in cervical spinal fusion demonstrated the safety and efficacy of i-FACTOR putty compared to standard-of-care autograft (clinicaltrials.gov NCT00310440.) The results demonstrated that i-FACTOR putty was statistically non-inferior to autograft for fusion success, improvement in Neck Disability Index (NDI) scores, neurological success and number of adverse events, at both the 1 and 2 year time point. The i-FACTOR putty was demonstrated to be statistically superior to autograft, at both 1 year and 2-years, for "overall success" which measures the patients that were successful in all of the test modalities.

Cerapedics is developing a new bone graft product formulation to enhance our product portfolio, specifically a P15-based bone graft that is appropriate for lumbar spinal fusion, called P-15L. The new formulation comprises two new materials as compared to the original i-FACTOR putty. The first is the use of porcine-derived anorganic bone mineral (ABM) as the anorganic bone matrix. The second modification is the use of bovine collagen as the inert carrier for the anorganic bone granules. The introduction of collagen as the inert carrier will allow the P-15L to be used in a TLIF surgical indication since the collagen component provides material integrity for the putty in the implant site. ;

Related Conditions & MeSH terms

• Back Pain
• Back Pain With Radiation
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Radiculopathy
• Radiculopathy Lumbar

• NCT number: NCT03502057
• Study type: Interventional
• Source: Northwestern University
• Contact: Surabhi Bhatt, BS
• Phone: 312-472-6024
• Email: surabhi.bhatt@nm.org
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Completion date: December 31, 2019