Clinical Outcomes Study Evaluating the Zero-P PEEK

Study Overview
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Brief Summary
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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.

Detailed Description
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This was a post-market study

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

Conditions
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Cervical Disc Disease

Intervention / Treatment
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* Device: Zero-P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: i. herniated nucleus pulposus ii. spondylosis (defined by presence of osteophytes) iii. loss of disc height 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Treatment of cervical DDD with the Zero-P device | Device: Zero-P<br>* 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.<br>* Other names: Zero-P PEEK Spacer;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCDD