Intervertebral Disk DegenerationNCT00310440

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

A study testing P-15 Synthetic osteoconductive bone substitute and Autologous bone in people with Intervertebral Disk Degeneration, run by CeraPedics, Inc at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Intervertebral Disk Degeneration
What is being tested?: P-15 Synthetic osteoconductive bone substitute and Autologous bone
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 319 participants
Where: 12 sitesin 2 countries
Study dates: Jan 2006to 23 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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).

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States10 sites

Cleveland Clinic
Cleveland, Ohio, 44195
Orthopaedics Northeast/Midwest Spine Group
Fort Wayne, Indiana, 46825
Indiana Spine Group
Indianapolis, Indiana, 46260
Indianapolis Neurosurgical Group
Indianapolis, Indiana, 46260
Kansas University Medical Center
Kansas City, Kansas, 66160-0001
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
Department of Neurological Surgery UCSF Spine Center
San Francisco, California, 94143
Sarasota Memorial Hospital
Sarasota, Florida, 34233
New England Neurosurgical Associates, LLC
Springfield, Massachusetts, 01104
Spine Education Research Institute
Thornton, Colorado, 80229

Other trials in United States

Canada2 sites

Foothills Medical Center
Calgary, Alberta, T2N 2T9
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4

Other trials in Canada

About this study

Read the 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.

Conditions: Intervertebral Disk Degeneration
Being tested: P-15 Synthetic osteoconductive bone substitute, Autologous bone
Keywords: Degenerative disc disease, P-15 Bone Putty, Bone graft, Cervical discectomy, Cervical spine
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P-15 Synthetic osteoconductive bone substituteDevice
Also called i-Factor
Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
Autologous boneOther
Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Study groups in NCT00310440
Study group	Role	What they receive
Bone graft substitute	Experimental	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). Receives: Device: P-15 Synthetic osteoconductive bone substitute
Autologous Bone	Active comparator	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. Receives: Other: Autologous bone

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiologic Fusion
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.
Measured: 12 months
Change in of the Overall Neck Disability Index (NDI) Score From Baseline.
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.
Measured: 12 months
Neurologic Success
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.
Measured: 12 months
Complications
Any AE within 12 months of surgery.
Measured: 12 months

Secondary outcomes (6)

Mean Change in Pain at Neck Visual Analog Scale (VAS).
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.
Measured: Baseline and 12 months
Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
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.
Measured: Baseline and 12 months
Success Rates Measured by Aggregated Modified Odom's Criteria
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%).
Measured: 12 months
Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).
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).
Measured: Baseline and 12 months
Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).
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).
Measured: Baseline and 12 months
Kyphosis
Kyphosis is evaluated in degrees.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 200623 May 2019

First posted4 Apr 2006 (estimated)
Study startJan 2006
Primary completionMay 2014
Study completion23 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intervertebral Disk DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310440
Sponsor's protocol ID: 1003
Status last verified: Mar 2020
First submitted: 3 Apr 2006
Last updated: 12 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Arnold PM, Vaccaro AR, Sasso RC, Goulet B, Fehlings MG, Heary RF, Janssen ME, Kopjar B. Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion. Neurosurgery. 2023 Apr 1;92(4):725-733. doi: 10.1227/neu.0000000000002290. Epub 2022 Dec 23.
PubMed 36700705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intervertebral Disk Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
ClinicalTrials.gov ID: NCT00310440
Acronym / sponsor ID: 1003
Conditions: Intervertebral Disk Degeneration
Keywords: Degenerative disc disease, P-15 Bone Putty, Bone graft, Cervical discectomy, Cervical spine
Study type: Interventional
Recruitment status: Completed
Enrolment: 319 participants (actual)
Lead sponsor: CeraPedics, IncIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: May 2014 (actual)
Study completion: 23 May 2019 (actual)
First posted: 4 Apr 2006 (estimated)
Results: Posted 10 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bone graft substitute	Experimental	Device: P-15 Synthetic osteoconductive bone substituteSubjects 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).
Autologous Bone	Active comparator	Other: Autologous boneSubjects 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (1 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P-15 Synthetic osteoconductive bone substituteAlso: i-FactorSafety and efficacy of synthetic bone substitute used for fusion in spinal surgery	Device	Bone graft substitute
Autologous boneLocal autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring	Other	Autologous Bone

Primary outcome

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.

6 secondary outcomes

Mean Change in Pain at Neck Visual Analog Scale (VAS).
Time frame: Baseline and 12 months
Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
Time frame: Baseline and 12 months
Success Rates Measured by Aggregated Modified Odom's Criteria
Time frame: 12 months
Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).
Time frame: Baseline and 12 months
Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).
Time frame: Baseline and 12 months
Kyphosis
Time frame: 12 months

Results and safety

Results posted to the registry on 10 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bone Graft Substitute	165	139
Autologous Bone	154	141

Primary outcome: Radiologic Fusion

Time frame: 12 months. Number. Unit: participants

Measure	Bone Graft Substitute n = 145	Autologous Bone n = 141
Fused	129	121
No Evidence of Fusion	16	20

Population analysed: All participants that have radiological data at 12 months including imputed data.

Primary outcome: Change in of the Overall Neck Disability Index (NDI) Score From Baseline.

Time frame: 12 months. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Bone Graft Substitute n = 161	Autologous Bone n = 152
Value	28.75 (25.81 to 31.69)	27.40 (24.35 to 30.45)

Population analysed: Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.

Primary outcome: Neurologic Success

Time frame: 12 months. Number. Unit: participants

Measure	Bone Graft Substitute n = 143	Autologous Bone n = 143
Yes	134	133
No	9	10

Population analysed: The total number of observed subjects.

Primary outcome: Complications

Time frame: 12 months. Number. Unit: participants

Measure	Bone Graft Substitute n = 165	Autologous Bone n = 154
Yes	138	127
No	27	27

Population analysed: All enrolled subjects.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected at all visits between baseline and 24 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bone Graft Substitute	45 of 165 (27.3%)	136 of 165 (82.4%)	Not reported
Autologous Bone	35 of 154 (22.7%)	128 of 154 (83.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36700705Arnold PM, Vaccaro AR, Sasso RC, Goulet B, Fehlings MG, Heary RF, Janssen ME, Kopjar B. Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion. Neurosurgery. 2023 Apr 1;92(4):725-733. doi: 10.1227/neu.0000000000002290. Epub 2022 Dec 23.

Related trials for Intervertebral Disk Degeneration

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Janssen, MD / DO principal investigator

Spine Education Research Institute

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing P-15 Synthetic osteoconductive bone substitute and Autologous bone in people with Intervertebral Disk Degeneration, run by CeraPedics, Inc at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiologic Fusion (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00310440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.