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Clinical Outcomes Study Evaluating the Zero-P PEEK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945243
Recruitment Status : Terminated (This study was terminated early due to lower than expected enrollment rates.)
First Posted : July 24, 2009
Results First Posted : January 13, 2017
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

Brief 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. Up to fifteen (15) sites will participate in this study. This is not a controlled study.

Condition or disease Intervention/treatment Phase
Cervical Disc Disease Device: Zero-P Not Applicable

Detailed Description:
This was a post-market study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : December 1, 2011
Actual Study Completion Date : December 1, 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Treatment of cervical DDD with the Zero-P device
Device: Zero-P
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.
Other Name: Zero-P PEEK Spacer

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Improvement in the Neck and Arm Visual Analog Pain Scale (VAS) [ Time Frame: 24 months ]
    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.

  2. Implant Related Complications [ Time Frame: 24 months ]
    Percentage of subjects who had an implant related complication

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:

    1. Neck or arm (radicular) pain and/or
    2. Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least one of the following:

    i. herniated nucleus pulposus

    ii. spondylosis (defined by presence of osteophytes)

    iii. loss of disc height

  2. NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
  3. Skeletally mature adult between the ages of 18-70 years at the time of surgery;
  4. Has completed at least six (6) weeks of conservative therapy;
  5. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
  6. 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.

Exclusion Criteria:

  1. More than one vertebral level to be fused;
  2. Posterior instrumentation necessary at same level;
  3. Has had previous surgery at the index level;
  4. Has a fused level adjacent to the index level;
  5. Active systemic or local infection;
  6. Known or documented history of communicable disease, including AIDS or HIV;
  7. Active hepatitis (receiving medical treatment within two years);
  8. 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;
  9. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
  10. Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
  11. 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.
  12. Previous known allergy to the materials contained in the device, such as polyetheretherketone (PEEK) or titanium alloy (TAN);
  13. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
  14. 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;
  15. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
  16. Pregnant or planning to become pregnant during study period;
  17. Involved in study of another investigational product that may affect outcome;
  18. History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
  19. Patients who are incarcerated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945243

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United States, Alabama
Neurospine, South East Alabama Medical Center
Dothan, Alabama, United States, 36301
United States, Arizona
Barrow Neurosurgical Institute
Phoenix, Arizona, United States, 85013
United States, California
Newport Orthopaedics, Hoag Hospital
Newport Beach, California, United States, 92660
United States, Florida
Lyerly Neurosurgery Group
Jacksonville, Florida, United States, 32207
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Spine Center
Lafayette, Indiana, United States, 46041
United States, Massachusetts
The Boston Spine Group
Newton, Massachusetts, United States, 02458
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Sierra Neurosurgery Group
Reno, Nevada, United States, 89502
Reno Orthopaedic Clinic
Reno, Nevada, United States, 89503
United States, Pennsylvania
VSAS Orthopaedics
Allentown, Pennsylvania, United States, 18103
United States, South Carolina
Charleston Neurosurgical Associates
Charleston, South Carolina, United States, 29414
United States, Washington
Neurosurgery Northwest
Tacoma, Washington, United States, 98405
United States, Wisconsin
Milwaukee Spinal Specialists
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Synthes USA HQ, Inc.
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Study Director: Mark Lotito DePuy Synthes Assoc. Director Clinical Research

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Responsible Party: Synthes USA HQ, Inc. Identifier: NCT00945243     History of Changes
Other Study ID Numbers: ZeroP-021109
First Posted: July 24, 2009    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: November 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Synthes USA HQ, Inc.:
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases