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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CeraPedics, Inc
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00310440
First received: April 3, 2006
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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..


Condition Intervention Phase
Degenerative Disc Disease in Cervical Spine
 Device: P-15 Synthetic osteoconductive bone substitute
Other: Autologous bone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Radiologic fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Neck Disability Index (NDI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Neurologic Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety Outcomes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain Neck Visual Analog Scale (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pain shoulder and arm Visual Analog Scale (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Success rates measured by aggregated modified Odom's criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Short Form 36 v2 Physical Health Composite Score (PCS) and Mental Health Composite Score (MCS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Kyphosis [ Time Frame: 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 310
Study Start Date: January 2006
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone graft substitute
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 investigational device (P15).
 Device: P-15 Synthetic osteoconductive bone substitute
Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
Other Name: i-Factor
Active Comparator: Autologous Bone
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.
 Other: Autologous bone
Local autologous bone will be harvested, milled and placed into teh cavity o fthe structural allograft ring

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 strenght 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 boney 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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310440

  Show 26 Study Locations
Sponsors and Collaborators
AO Clinical Investigation and Documentation
CeraPedics, Inc
Investigators
Principal Investigator: Michael Janssen, MD / DO Spine Education Research Institute
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00310440     History of Changes
Other Study ID Numbers: 06-P15-04
Study First Received: April 3, 2006
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by AO Clinical Investigation and Documentation:
Degenerative disc disease
P-15 Bone Putty
Bone graft
Cervical discectomy

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013