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Clinical Outcomes Study Evaluating the Zero-P PEEK

This study has been terminated.
(This study was terminated early due to lower than expected enrollment rates.)
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00945243
First received: July 22, 2009
Last updated: January 16, 2017
Last verified: January 2017
  Purpose
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 Intervention
Cervical Disc Disease
Device: Zero-P

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Assessment of Neck Disability Index (NDI) Scores [ Time Frame: 24 months ]

    the NDI is a patient-completed questionnaire with 10 items including: pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale, in which 0 means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score either as a raw score, with a maximum score of 50, or as a percentage with 0 points or 0% meaning 'no activity limitations' and 50 points or 100% meaning 'complete activity limitation'.

    This study analyzed the percentage of subjects who experienced a maintenance (same NDI score as baseline) or improvement (lower NDI score compared to baseline) according to measures of pain and/or function.



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

    The VAS is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is presented as a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" (0mm) and "worst pain imaginable" (100mm).

    This study analyzed the percentage of subjects who experienced a maintenance (same VAS score as compared to baseline) or improvement (lower VAS score as compared to baseline) in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.


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


Enrollment: 11
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
This was a post-market study
  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945243

Locations
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
St. 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.
Investigators
Study Director: Mark Lotito DePuy Synthes Assoc. Director Clinical Research
  More Information

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00945243     History of Changes
Other Study ID Numbers: ZeroP-021109
Study First Received: July 22, 2009
Results First Received: November 17, 2016
Last Updated: January 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Synthes USA HQ, Inc.:
SCDD

ClinicalTrials.gov processed this record on May 25, 2017