- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310440
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Center
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Quebec
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Montreal, Quebec, Canada, H3A 2B4
- Montreal Neurological Institute
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California
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San Francisco, California, United States, 94143
- Department of Neurological Surgery UCSF Spine Center
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Colorado
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Thornton, Colorado, United States, 80229
- Spine Education Research Institute
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Florida
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Sarasota, Florida, United States, 34233
- Sarasota Memorial Hospital
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Indiana
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Fort Wayne, Indiana, United States, 46825
- Orthopaedics Northeast/Midwest Spine Group
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Indianapolis, Indiana, United States, 46260
- Indiana Spine Group
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Indianapolis, Indiana, United States, 46260
- Indianapolis Neurosurgical Group
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Kansas
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Kansas City, Kansas, United States, 66160-0001
- Kansas University Medical Center
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Massachusetts
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Springfield, Massachusetts, United States, 01104
- New England Neurosurgical Associates, LLC
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah Orthopaedic Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
Other Names:
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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.
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Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiologic Fusion
Time Frame: 12 months
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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.
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12 months
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Change in of the Overall Neck Disability Index (NDI) Score From Baseline.
Time Frame: 12 months
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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.
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12 months
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Neurologic Success
Time Frame: 12 months
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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.
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12 months
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Complications
Time Frame: 12 months
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Any AE within 12 months of surgery.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Pain at Neck Visual Analog Scale (VAS).
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Success Rates Measured by Aggregated Modified Odom's Criteria
Time Frame: 12 months
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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%).
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12 months
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Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).
Time Frame: Baseline and 12 months
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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).
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Baseline and 12 months
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Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).
Time Frame: Baseline and 12 months
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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).
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Baseline and 12 months
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Kyphosis
Time Frame: 12 months
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Kyphosis is evaluated in degrees.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Janssen, MD / DO, Spine Education Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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