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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:
Information provided by (Responsible Party):
CeraPedics, Inc
ClinicalTrials.gov Identifier:
NCT00310440
First received: April 3, 2006
Last updated: January 13, 2016
Last verified: January 2016

April 3, 2006
January 13, 2016
January 2006
May 2014   (final data collection date for primary outcome measure)
  • Radiologic Fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.
  • Change in of the Overall Neck Disability Index (NDI) Score From Baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.
  • Neurologic Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.
  • Complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any AE within 12 months of surgery.
  • The difference in the fusion rates at twelve months between the investigational device and the control group will be greater than -ten
  • The difference in average neck disability index values at twelve months between the investigational device and the control group will be greater than eleven points.
  • Difference in pain (arm) measured by VAS at twelve months between the investigational and the control group will be greater than 1,8 points
  • Difference in pain (neck) measured by VAS at twelve months between the investigational and the control group will be greater than 1.8 points
Complete list of historical versions of study NCT00310440 on ClinicalTrials.gov Archive Site
  • Mean Change in Pain at Neck Visual Analog Scale (VAS). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from "No pain at all" (0) to "Worst imaginable pain" (10). The change in pain is calculated by subtracting the 12 month score from the baseline score.
  • Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from "No pain at all" (0) to "Worst imaginable pain" (10). The change in pain is calculated by subtracting the 12 month score from the baseline score.
  • Success Rates Measured by Aggregated Modified Odom's Criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).
  • Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).
  • Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS). [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).
  • Kyphosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Kyphosis is evaluated in degrees.
  • Kyphosis rates at twelve months will not differ between the experimental and the control group
  • Standardized SF-36 and composite scores (PCS and MCS) values at twelve months will not differ between the experimental and the control group
  • Success rates measured by aggregated modified Odom's criteria at twelve months will differ between the experimental and the control group
  • Complication rates at twelve months will differ between the experimental and the control group
Not Provided
Not Provided
 
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
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..

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Intervertebral Disk Degeneration
  • Device: P-15 Synthetic osteoconductive bone substitute
    Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
    Other Name: i-Factor
  • Other: Autologous bone
    Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
  • 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 P-15 synthetic osteoconductive bone substitute (investigational device).
    Intervention: Device: P-15 Synthetic osteoconductive bone substitute
  • 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.
    Intervention: Other: Autologous bone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
319
May 2019
May 2014   (final data collection date for primary outcome measure)

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).

Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00310440
1003
Yes
Not Provided
Not Provided
CeraPedics, Inc
CeraPedics, Inc
Not Provided
Principal Investigator: Michael Janssen, MD / DO Spine Education Research Institute
CeraPedics, Inc
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP