Cervical Disc DiseaseNCT00945243

Clinical Outcomes Study Evaluating the Zero-P PEEK

A study testing Zero-P in people with Cervical Disc Disease, run by Synthes USA HQ, Inc. at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cervical Disc Disease
What is being tested?: Zero-P
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 14 sitesUnited States
Study dates: 1 Jul 2009to 1 Dec 2011
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

Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:
Neck or arm (radicular) pain and/or
Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least one of the following:
herniated nucleus pulposus
spondylosis (defined by presence of osteophytes)
loss of disc height

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NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
Skeletally mature adult between the ages of 18-70 years at the time of surgery;
Has completed at least six (6) weeks of conservative therapy;
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.

Who cannot join

More than one vertebral level to be fused;
Posterior instrumentation necessary at same level;
Has had previous surgery at the index level;
Has a fused level adjacent to the index level;
Active systemic or local infection;
Known or documented history of communicable disease, including AIDS or HIV;

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Active hepatitis (receiving medical treatment within two years);
Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1.0.
Previous known allergy to the materials contained in the device, such as polyetheretherketone (PEEK) or titanium alloy (TAN);
Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
Pregnant or planning to become pregnant during study period;
Involved in study of another investigational product that may affect outcome;
History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
Patients who are incarcerated.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

VSAS Orthopaedics
Allentown, Pennsylvania, 18103
Charleston Neurosurgical Associates
Charleston, South Carolina, 29414
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Neurospine, South East Alabama Medical Center
Dothan, Alabama, 36301
Lyerly Neurosurgery Group
Jacksonville, Florida, 32207
Indiana Spine Center
Lafayette, Indiana, 46041
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, 53211
Newport Orthopaedics, Hoag Hospital
Newport Beach, California, 92660
The Boston Spine Group
Newton, Massachusetts, 02458
Barrow Neurosurgical Institute
Phoenix, Arizona, 85013
Sierra Neurosurgery Group
Reno, Nevada, 89502
Reno Orthopaedic Clinic
Reno, Nevada, 89503
Washington University School of Medicine
St Louis, Missouri, 63110
Neurosurgery Northwest
Tacoma, Washington, 98405

Other trials in United States

About this study

Official title: Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease

Read the detailed description

This was a post-market study

Conditions: Cervical Disc Disease
Being tested: Zero-P
Keywords: SCDD

What participants receive

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

Zero-PDevice
Also called Zero-P PEEK Spacer
The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Study groups in NCT00945243
Study group	Role	What they receive
Treatment	Other	Treatment of cervical DDD with the Zero-P device Receives: Device: Zero-P

What is being measured

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

Assessment of Neck Disability Index Scores
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
Measured: 24 months

Secondary outcomes (2)

Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.
Measured: 24 months
Implant Related Complications
Percentage of subjects who had an implant related complication
Measured: 24 months

Timeline

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

1 Jul 20091 Dec 2011

First posted24 Jul 2009 (estimated)
Study start1 Jul 2009
Primary completion1 Dec 2011
Study completion1 Dec 2011

Why it stopped: This study was terminated early due to lower than expected enrollment rates.

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.
Other trials for Cervical Disc DiseaseStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00945243
Sponsor's protocol ID: ZeroP-021109
Status last verified: Sep 2017
First submitted: 22 Jul 2009
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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

Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine

All Cervical Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease
ClinicalTrials.gov ID: NCT00945243
Acronym / sponsor ID: ZeroP-021109
Conditions: Cervical Disc Disease
Keywords: SCDD
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to lower than expected enrollment rates.
Enrolment: 11 participants (actual)
Lead sponsor: Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jul 2009 (actual)
Primary completion: 1 Dec 2011 (actual)
Study completion: 1 Dec 2011 (actual)
First posted: 24 Jul 2009 (estimated)
Results: Posted 13 Jan 2017

Clinical summary

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

Detailed description

This was a post-market study

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Device: Zero-PTreatment of cervical DDD with the Zero-P device

Who may qualify

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

Key inclusion criteria (11 listed)

Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:
NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
Skeletally mature adult between the ages of 18-70 years at the time of surgery;
Has completed at least six (6) weeks of conservative therapy;
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;

Key exclusion criteria (19 listed)

More than one vertebral level to be fused;
Posterior instrumentation necessary at same level;
Has had previous surgery at the index level;
Has a fused level adjacent to the index level;
Active systemic or local infection;

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
Zero-PAlso: Zero-P PEEK SpacerThe Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.	Device	Treatment

Primary outcome

Assessment of Neck Disability Index Scores
Time frame: 24 months
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.

2 secondary outcomes

Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
Time frame: 24 months
Implant Related Complications
Time frame: 24 months

Results and safety

Results posted to the registry on 13 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	11	8

Primary outcome: Assessment of Neck Disability Index Scores

Time frame: 24 months. Number. Unit: percentage of subjects

Measure	Treatment n = 8
Value	87.5

Population analysed: 8 subjects had data at 24 months

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment out to 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 11 (0%)	3 of 11 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cervical Disc Disease

Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine

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.

Mark Lotito study director

DePuy Synthes Assoc. Director Clinical Research

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zero-P in people with Cervical Disc Disease, run by Synthes USA HQ, Inc. at 14 sites in United States.

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 19 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: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 13 Jan 2017). 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?

Assessment of Neck Disability Index Scores (time frame: 24 months). 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 NCT00945243.

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 6 Nov 2017.