An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Participant); Primary Purpose: Treatment
Condition:	Intervertebral Disk Degeneration
Interventions:	Device: P-15 Synthetic osteoconductive bone substitute Other: Autologous bone

Participant Flow

Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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). P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
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. Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Description

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).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

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.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Participant Flow: Overall Study

	Bone Graft Substitute	Autologous Bone
STARTED	165	154
COMPLETED	139	141
NOT COMPLETED	26	13
Lost to Follow-up	17	8
Withdrawal by Subject	2	1
Missed 12 Month Visit	7	4

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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). P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
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. Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Total	Total of all reporting groups

Description

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).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

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.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Total

Total of all reporting groups

Baseline Measures

	Bone Graft Substitute	Autologous Bone	Total
Overall Participants Analyzed [Units: Participants]	165	154	319

Age [Units: Years] Mean (Standard Deviation)	47.7 (9.7)	45.7 (9.4)	46.8 (9.6)

Gender [Units: Participants]
Female	95	97	192
Male	70	57	127

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	7	4	11
Not Hispanic or Latino	157	150	307
Unknown or Not Reported	1	0	1

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	1	0	1
Asian	4	1	5
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	6	11
White	151	144	295
More than one race	0	0	0
Unknown or Not Reported	4	3	7

Region of Enrollment [Units: Participants]
Canada	29	26	55
United States	136	128	264

Outcome Measures

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1. Primary:

Radiologic Fusion [ Time Frame: 12 months ]

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2. Primary:

Change in of the Overall Neck Disability Index (NDI) Score From Baseline. [ Time Frame: 12 months ]

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3. Primary:

Neurologic Success [ Time Frame: 12 months ]

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4. Primary:

Complications [ Time Frame: 12 months ]

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5. Secondary:

Mean Change in Pain at Neck Visual Analog Scale (VAS). [ Time Frame: Baseline and 12 months ]

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6. Secondary:

Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS). [ Time Frame: Baseline and 12 months ]

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7. Secondary:

Success Rates Measured by Aggregated Modified Odom's Criteria [ Time Frame: 12 months ]

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8. Secondary:

Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS). [ Time Frame: Baseline and 12 months ]

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9. Secondary:

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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10. Secondary:

Kyphosis [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Lead Clinical Research Associate
Organization: Nor Consult, LLC
phone: 2066076861
e-mail: p15@nor-consult.com

Responsible Party:	CeraPedics, Inc
ClinicalTrials.gov Identifier:	NCT00310440 History of Changes
Other Study ID Numbers:	1003
Study First Received:	April 3, 2006
Results First Received:	December 10, 2015
Last Updated:	January 13, 2016