An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
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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 |
- 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 ]
- 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 |
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
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 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Orthopaedics Northeast/Midwest Spine Group | |
| Ft. Wayne, Indiana, United States, 46825 | |
| Indianapolis Neurosurgical Group | |
| Indianapolis, Indiana, United States, 46260 | |
| Indiana Spine 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 | |
| St. 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 Clinic | |
| 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 | |
| Canada, Alberta | |
| Foothills Medical Center | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Ontario | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Canada, Quebec | |
| Montreal Neurological Institute | |
| Montreal, Quebec, Canada, H3A 2B4 | |
| 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 June 18, 2013