Overview

This trial is active, not recruiting.

Condition intervertebral disk degeneration
Treatments p-15 synthetic osteoconductive bone substitute, autologous bone
Sponsor CeraPedics, Inc
Start date January 2006
End date May 2014
Trial size 319 participants
Trial identifier NCT00310440, 1003

Summary

The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).
p-15 synthetic osteoconductive bone substitute i-Factor
Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
(Active Comparator)
Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.
autologous bone
Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Primary Outcomes

Measure
Radiologic fusion
time frame: 12 months
Neck Disability Index (NDI)
time frame: 12 months
Neurologic success
time frame: 12 months
Adverse events
time frame: 12 months

Secondary Outcomes

Measure
Pain neck Visual Analog Scale (VAS)
time frame: 12 months
Pain shoulder and arm Visual Analog Scale (VAS)
time frame: 12 months
Success rates measured by aggregated modified Odom's criteria
time frame: 12 months
Short Form 36 v2 Physical Health Composite Score (PCS)
time frame: 12 months
Short Form 36 v2 Mental Health Composite Score (MCS)
time frame: 12 months
Kyphosis
time frame: 12

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Age between 18 and 65 - Radiographically determined discogenic origin to include at least one of the following characteristics: degenerated/dark disc on MRI, decreased disc height compared to adjacent levels on radiographic film, CT, or MRI and disc herniation on CT or MRI - Radicular symptoms by history and physical exam to include at least the following characteristics: Arm/shoulder pain, decreased flexes, decreased strength and abnormal sensation - Pain level arm/shoulder >4 on 0-10 VAS - Pain level neck >4 on 0-10 VAS - Neck disability Index >30 - Involved discs between C3 and C7 - Undergoing anterior cervical fusion at a single level - Failed to gain adequate relief from non-operative treatment - Able and willing to give consent to participate in study - Understand and read English at elementary level Exclusion Criteria: Systemic infection such as AIDS, HIV, and active hepatitis; Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis or osteomalacia; Taking medication for the prevention of osteoporosis; Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk; Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.); Multiple level symptomatic degenerative disc disease; Previous cervical fusion; Previous cervical decompression at the same level; Acute cervical trauma or instability (i.e., subluxation > 3 mm on flexion/extension radiographic film); Undergoing treatment for tumor or bony traumatic injury to the cervical spine; Rheumatoid disease of the cervical spine; Myelopathy; Pregnant or planning to become pregnant in the next 2 years; Posterior cervical spine procedure scheduled; More than one level to be operated; Has a history of substance abuse (recreational drugs, alcohol); Is a prisoner; Is currently involved in a study of another investigational product for similar purpose; Has a disease process that would preclude accurate evaluation (e.g., neuromuscular disease, significant psychiatric disease).

Additional Information

Official title An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Principal investigator Michael Janssen, MD / DO
Description Anterior Cervical Discectomy and Fusion (ACDF) is a common surgical treatment option for symptomatic degenerative cervical disk disease in patients who fail conservative treatment. i-FACTOR bone graft is a unique anorganic bone mineral (ABM) and small peptide, P-15™. P-15 is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins. This is randomized, controlled, multi-center, prospective FDA IDE study conducted to assess the safety and effectiveness of i-FACTOR bone graft (Cerapedics, Inc. Westminster, CO) in patients treated with single level ACDF. Patients received i-FACTOR bone graft or local autologous bone inside a structural allograft.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by CeraPedics, Inc.