An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
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|ClinicalTrials.gov Identifier: NCT00310440|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2006
Results First Posted : February 10, 2016
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intervertebral Disk Degeneration||Device: P-15 Synthetic osteoconductive bone substitute Other: Autologous bone||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2019|
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).
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 the cavity of the structural allograft ring
- Radiologic Fusion [ Time Frame: 12 months ]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 ]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 ]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 ]Any AE within 12 months of surgery.
- Mean Change in Pain at Neck Visual Analog Scale (VAS). [ Time Frame: Baseline and 12 months ]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 ]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 ]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 ]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 ]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 ]Kyphosis is evaluated in degrees.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310440
Hide Study Locations
|United States, California|
|Todd Lanman, MD, Inc.|
|Beverly Hills, California, United States, 90210|
|Department of Neurological Surgery UCSF Spine Center|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|Spine Education Research Institute|
|Thornton, Colorado, United States, 80229|
|United States, Florida|
|Sarasota Memorial Hospital|
|Sarasota, Florida, United States, 34233|
|United States, Illinois|
|Loyola University - Chicago|
|Maywood, Illinois, United States, 60153|
|United States, Indiana|
|Orthopaedics Northeast/Midwest Spine Group|
|Fort Wayne, Indiana, United States, 46825|
|Indiana Spine Group|
|Indianapolis, Indiana, United States, 46260|
|Indianapolis Neurosurgical Group|
|Indianapolis, Indiana, United States, 46260|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160-0001|
|United States, Maryland|
|Maryland Brain & Spine|
|Annapolis, Maryland, United States, 21401|
|United States, Massachusetts|
|New England Baptist Hospital|
|Boston, Massachusetts, United States, 02120|
|New England Neurosurgical Associates, LLC|
|Springfield, Massachusetts, United States, 01104|
|United States, Missouri|
|Washington University Orthopedics|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|New Jersey Medical School|
|Newark, New Jersey, United States, 07101-2425|
|United States, New York|
|Buffalo Spine Surgery|
|Lockport, New York, United States, 14094|
|United States, North Carolina|
|Carolina NeuroSurgery & Spine Associates|
|Charlotte, North Carolina, United States, 28204|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Oregon|
|NeuroSpine Institute LLC|
|Eugene, Oregon, United States, 97401|
|United States, Pennsylvania|
|Thomas Jefferson University and Rothman Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah Orthopaedic Center|
|Salt Lake City, Utah, United States, 84108|
|United States, Virginia|
|Spinal Research Foundation|
|Reston, Virginia, United States, 20190|
|United States, Washington|
|Harborview Medical Center, University of Washington|
|Seattle, Washington, United States, 98104|
|Foothills Medical Center|
|Calgary, Alberta, Canada, T2N 2T9|
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Montreal Neurological Institute|
|Montreal, Quebec, Canada, H3A 2B4|
|Principal Investigator:||Michael Janssen, MD / DO||Spine Education Research Institute|