Cervical Intervertebral Disc Degeneration
Conditions
Keywords
Total Disc Replacement
Brief summary
The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.
Detailed description
The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled. Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.
Interventions
DEVICENuNec Cervical Disc
Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
Sponsors
Pioneer Surgical Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* is at least 21 years of age and skeletally mature * must have symptomatic degenerative disc disease at one level in the cervical spine, C3 to C7, demonstrated by herniated disc and/or spondylosis; * must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment * must score at least 15/50 (30%) on the Neck Disability Index * is willing and able to follow the post-operative management program * must understand and sign the informed consent document
Exclusion criteria
* symptomatic cervical DDD at more than one level * axial neck pain as the primary diagnosis without evidence of neural compression * neck or arm pain of unknown etiology * any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible * severe spondylosis at the target level * prior surgery at the target level * fused level adjacent to the target level * osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease * active infection or surgical site infection * is using any medication known to interfere with bone/soft tissue healing * diabetes mellitus requiring daily insulin management * any terminal, systemic, or autoimmune disease * medical conditions or mental incompetence which may interfere with study requirements * BMI \>40 or a weight more than 100 lbs over ideal body weight * chemical dependency problem that may interfere with study requirements * current smokers * history of any invasive malignancy unless treated and in remission for at least two years * documented allergies to metal or plastic * currently pregnant, or interested in becoming pregnant during the study follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) Score Improvement of at Least 15 Points | At 24 months | The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve. |
| Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain | At 24 months | The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]). A higher score would indicate that the patient had a worse outcome. |
| Serious Adverse Events Related to the Device | Up to 24 months | The number of serious adverse events have been recorded |
| Device Failures or Removals, Revisions, Re-operations | Up to 24 months | The failures or re-operations or supplemental fixation at the treated level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | At 24 months | As assessed on patient questionnaire. |
| Absence of Device Migration or Subsidence | Up to 24 months | Absence of device migration \> 3mm; Absence of device subsidence \> 3mm |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NuNec Cervical Disc Each patient will be implanted with the NuNec Cervical Disc in a single level from C3 to C7. Postoperatively, patient evaluated at discharge, 6 weeks, 3, 6, 12 and 24 months.
NuNec Cervical Disc: Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | NuNec Cervical Disc |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Device Failures or Removals, Revisions, Re-operations
The failures or re-operations or supplemental fixation at the treated level
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuNec Cervical Disc | Device Failures or Removals, Revisions, Re-operations | 0 Participants |
Primary
Neck Disability Index (NDI) Score Improvement of at Least 15 Points
The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.
Time frame: At 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NuNec Cervical Disc | Neck Disability Index (NDI) Score Improvement of at Least 15 Points | 28.4 units on a scale | Standard Deviation 27.1 |
p-value: <0.05ANOVA
Primary
Serious Adverse Events Related to the Device
The number of serious adverse events have been recorded
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuNec Cervical Disc | Serious Adverse Events Related to the Device | 0 Participants |
Primary
Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain
The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]). A higher score would indicate that the patient had a worse outcome.
Time frame: At 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NuNec Cervical Disc | Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain | 2.97 units on a scale | Standard Deviation 3.27 |
p-value: <0.05ANOVA
Secondary
Absence of Device Migration or Subsidence
Absence of device migration \> 3mm; Absence of device subsidence \> 3mm
Time frame: Up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuNec Cervical Disc | Absence of Device Migration or Subsidence | 0 Participants |
Secondary
Patient Satisfaction
As assessed on patient questionnaire.
Time frame: At 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NuNec Cervical Disc | Patient Satisfaction | Very Satisfied | 3 Participants |
| NuNec Cervical Disc | Patient Satisfaction | Satisfied | 4 Participants |
| NuNec Cervical Disc | Patient Satisfaction | Somewhat Satisfied | 1 Participants |
| NuNec Cervical Disc | Patient Satisfaction | Unsatisfied | 0 Participants |