An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
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ClinicalTrials.gov Identifier: NCT00310440 |
Recruitment Status :
Completed
First Posted : April 4, 2006
Results First Posted : February 10, 2016
Last Update Posted : March 12, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment |
Condition |
Intervertebral Disk Degeneration |
Interventions |
Device: P-15 Synthetic osteoconductive bone substitute Other: Autologous bone |
Enrollment | 319 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Bone Graft Substitute | Autologous Bone |
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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). P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery |
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. Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring |
Period Title: Overall Study | ||
Started | 165 | 154 |
Completed | 139 | 141 |
Not Completed | 26 | 13 |
Reason Not Completed | ||
Lost to Follow-up | 17 | 8 |
Withdrawal by Subject | 2 | 1 |
Missed 12 Month Visit | 7 | 4 |
Arm/Group Title | Bone Graft Substitute | Autologous Bone | Total | |
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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). P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery |
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. Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring |
Total of all reporting groups | |
Overall Number of Baseline Participants | 165 | 154 | 319 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 165 participants | 154 participants | 319 participants | |
47.7 (9.7) | 45.7 (9.4) | 46.8 (9.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 165 participants | 154 participants | 319 participants | |
Female |
95 57.6%
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97 63.0%
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192 60.2%
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Male |
70 42.4%
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57 37.0%
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127 39.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 165 participants | 154 participants | 319 participants | |
Hispanic or Latino |
7 4.2%
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4 2.6%
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11 3.4%
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Not Hispanic or Latino |
157 95.2%
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150 97.4%
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307 96.2%
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Unknown or Not Reported |
1 0.6%
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0 0.0%
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1 0.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 165 participants | 154 participants | 319 participants | |
American Indian or Alaska Native |
1 0.6%
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0 0.0%
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1 0.3%
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Asian |
4 2.4%
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1 0.6%
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5 1.6%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 3.0%
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6 3.9%
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11 3.4%
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White |
151 91.5%
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144 93.5%
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295 92.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
4 2.4%
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3 1.9%
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7 2.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 165 participants | 154 participants | 319 participants |
Canada | 29 | 26 | 55 | |
United States | 136 | 128 | 264 |
Name/Title: | Lead Clinical Research Associate |
Organization: | Nor Consult, LLC |
Phone: | 2066076861 |
EMail: | p15@nor-consult.com |
Responsible Party: | CeraPedics, Inc |
ClinicalTrials.gov Identifier: | NCT00310440 |
Other Study ID Numbers: |
1003 |
First Submitted: | April 3, 2006 |
First Posted: | April 4, 2006 |
Results First Submitted: | December 10, 2015 |
Results First Posted: | February 10, 2016 |
Last Update Posted: | March 12, 2020 |