Clinical Outcomes Study Evaluating the Zero-P PEEK

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

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Disc Disease
• Intervention / Treatment: Device: Zero-P

Detailed Description

This was a post-market study

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 Names: Zero-P PEEK Spacer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
Implant Related Complications	Percentage of subjects who had an implant related complication	24 months

Collaborators and Investigators

• Sponsor: Synthes USA HQ, Inc.
• Investigators: Study Director: Mark Lotito, DePuy Synthes Assoc. Director Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: SCDD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: ZeroP-021109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO