Cervical Disc Disease
Conditions
Keywords
SCDD
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.
Detailed description
This was a post-market study
Interventions
DEVICEZero-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.
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Neck Disability Index Scores | 24 months | Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the Neck and Arm Visual Analog Pain Scale (VAS) | 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. |
| Implant Related Complications | 24 months | Percentage of subjects who had an implant related complication |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment of cervical DDD with the Zero-P device ACDF: 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. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Terminated: Subjects Dispositioned | 3 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Assessment of Neck Disability Index Scores
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
Time frame: 24 months
Population: 8 subjects had data at 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Assessment of Neck Disability Index Scores | 87.5 percentage of subjects |
Secondary
Implant Related Complications
Percentage of subjects who had an implant related complication
Time frame: 24 months
Population: 11 subjects were enrolled and treated on protocol and were thus considered for safety information
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Implant Related Complications | 0 percentage of subjects |
Secondary
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.
Time frame: 24 months
Population: 8 subjects had data at 24 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Improvement in the Neck and Arm Visual Analog Pain Scale (VAS) | 75.0 percentage of subjects |