Clinical trial NCT00310440: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Official title: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disk Degeneration
Keywords: Degenerative disc disease
P-15 Bone Putty
Bone graft
Cervical discectomy
Cervical spine
Lead sponsor: CeraPedics, Inc
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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..

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 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 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).

Primary outcomes:
measure: Radiologic Fusion
timeFrame: 12 months
measure: Change in of the Overall Neck Disability Index (NDI) Score From Baseline.
timeFrame: 12 months
measure: Neurologic Success
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
Secondary outcomes:
measure: Mean Change in Pain at Neck Visual Analog Scale (VAS).
timeFrame: Baseline and 12 months
measure: Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
timeFrame: Baseline and 12 months
measure: Success Rates Measured by Aggregated Modified Odom's Criteria
timeFrame: 12 months
measure: Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).
timeFrame: Baseline and 12 months
measure: Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).
timeFrame: Baseline and 12 months
measure: Kyphosis
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Department of Neurological Surgery UCSF Spine Center
state: California
city: Thornton
country: United States
facility: Spine Education Research Institute
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Fort Wayne
country: United States
facility: Orthopaedics Northeast/Midwest Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Neurosurgical Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Springfield
country: United States
facility: New England Neurosurgical Associates, LLC
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
Study officials:
affiliation: Spine Education Research Institute
name: Michael Janssen, MD / DO
role: PRINCIPAL_INVESTIGATOR
References: