Cervical Degenerative Disc Disease
Conditions
Brief summary
This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.
Detailed description
The objective of this clinical study is to evaluate the safety and effectiveness of the Simplify® Disc for treatment of DDD compared to conventional ACDF for reconstruction of the disc space at one level between C3 to C7 for DDD defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space that is unresponsive to conservative management.
Interventions
DEVICESimplify Disc
Simplify Disc at one level in the cervical spine.
This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial.
Sponsors
NuVasive
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Be between 18 and 60 years of age; * Have symptoms of cervical degenerative disc disease (DDD) at one cervical level from C3 to C7 defined as intractable radiculopathy (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space and radiographic evidence of at least one of the following; 1. Spondylosis (defined by the presence of osteophytes or dark disc) on CT or MRI or; 2. Disc height decreased by ≥ 1 mm when compared to adjacent levels on radiographic film, CT, or MRI or 3. Disc herniation on CT or MRI; * Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm; 1. Pain or paresthesias in a specific nerve root distribution from C3 to C7, 2. Decreased muscle strength of at least one level on the 0-5 scale, or 3. Abnormal sensation, including hyperesthesia or hypoesthesia. * Have at least one of the following: 1. At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose); 2. The presence of progressive symptoms (e.g., increasing numbness or tingling) or 3. Signs of nerve root compression. * Have a Neck Disability Index (NDI) greater than or equal to 40 on a scale of 100 (moderate disability); * Be appropriate for treatment using an anterior surgical approach; * Be likely to return for all follow-up visits and * Be willing and able to provide Informed Consent for study participation.
Exclusion criteria
* Marked cervical instability on resting lateral or flexion/ extension X-ray (translation \> 3 mm or \> 11 degrees rotation to that of either adjacent non-treatment level); * Non discogenic neck pain or non discogenic source of symptoms (e.g., tumor, rotator cuff injury, etc.); * Radiographic confirmation of severe facet disease or facet degeneration; * Bridging osteophytes; * Less than 2 degrees of motion at index level; * Prior surgery at the level to be treated, except laminotomy without accompanying facetectomy; * Prior fusion at any cervical level; * More than one neck surgery via anterior approach; * Previous trauma to the C3-C7 levels resulting in compression or bursting; * Documented presence of a free nuclear fragment at cervical levels other than the study level; * Axial neck pain only (no radicular or myelopathy symptoms); * Symptomatic DDD at more than one cervical level; * Severe myelopathy (less than 3/5 muscle strength); * Any paralysis; * Recent history (within previous six months) of chemical or alcohol dependence; * Active systemic infection; * Infection at the site of surgery; * Prior disc space infection or osteomyelitis in the cervical spine; * Any terminal, systemic or autoimmune disease; * Metabolic bone disease (e.g., osteoporosis/osteopenia , gout, osteomalacia, Paget's disease); * Any disease, condition or surgery which might impair healing, such as; 1. Diabetes mellitus requiring daily insulin management, 2. Active malignancy, 3. History of metastatic malignancy. * Current or extended use (\> 6 months) of any drug known to interfere with bone or soft tissue healing; * Known PEEK, ceramic, titanium allergy; * Arachnoiditis; * Significant cervical anatomical deformity at the index level or clinically compromised cervical vertebral bodies at the index level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion, or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis); * Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin; * Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery ; * Use of spinal stimulator at any cervical level prior to surgery; * Currently a prisoner; * Currently involved in spinal litigation which may influence the subjects reporting of symptoms or * Participation in any other investigational drug, biologic or medical device study within the last 30 days prior to study surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Clinical Success (CCS) of Simplify Disc | Baseline, 24 Months | Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Disc Height (Below the Index Level) | Baseline, 24 Months | Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights. |
| Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) | Baseline, 3 Months | Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function. |
| VAS Neck and Arm Pain | Baseline, 24 Months | Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain) |
| Neurological Status | Baseline, 24 Months | Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination. |
| SF-12 Physical Component Score (PCS) Maintenance or Improvement | Baseline, 24 Months | The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. |
| SF-12 Mental Component Score (MCS) Maintenance or Improvement | Baseline, 24 Months | The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. |
| Patient Questionnaires- Treatment Satisfaction Health Survey- | 24 Months | Question 1 - how does the subject rate satisfaction with the treated received was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied. |
| Odom's Criteria Results | 24 Months | Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria. |
| Dysphagia Handicap Index (DHI) | Baseline, 24 Months | Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. |
| Average Disc Height (Index Level) | Baseline, 24 Months | Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights. |
| Average Disc Height (Above the Index Level) | Baseline, 24 Months | Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights. |
| Superior Adjacent Level Disc Degeneration | Baseline, 24 Months | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level. |
| Inferior Adjacent Level Disc Degeneration | Baseline, 24 Months | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level. |
| Device Migration | Baseline, 24 Months | Device migration assesses significant movement of the implant postoperatively |
| Facet Deterioration | Baseline, 24 Months | Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited across 16 clinical sites in the United States
Pre-assignment details
This is a non-randomized study. The 117 ACDF subjects are a historical control group. (Kineflex C Study; NCT#00374413)
Participants by arm
| Arm | Count |
|---|---|
| Anterior Cervical Discectomy & Fusion (ACDF) Anterior Cervical Discectomy & Fusion: This study utilized a non-concurrent historical control with subject-level data on a parallel group design. The historical control group was formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial. | 117 |
| Simplify Disc Simplify Disc
Simplify Disc: Simplify Disc at one level in the cervical spine. | 150 |
| Total | 267 |
Baseline characteristics
| Characteristic | Anterior Cervical Discectomy & Fusion (ACDF) | Total | Simplify Disc |
|---|---|---|---|
| Age, Continuous | 44.1 Years STANDARD_DEVIATION 7 | 43.5 Years STANDARD_DEVIATION 8.13 | 43.0 Years STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) White | 103 Participants | 234 Participants | 131 Participants |
| Region of Enrollment United States | 117 Participants | 267 Participants | 150 Participants |
| Sex: Female, Male Female | 68 Participants | 159 Participants | 91 Participants |
| Sex: Female, Male Male | 49 Participants | 108 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 0 / 150 |
| other Total, other adverse events | 65 / 117 | 89 / 150 |
| serious Total, serious adverse events | 16 / 117 | 17 / 150 |
Outcome results
Primary
Number of Participants With Composite Clinical Success (CCS) of Simplify Disc
Individual success for the Simplify® Disc subjects is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months of index procedure; and the absence of major adverse events within 24 months. Individual success for the control ADCF device subjects is defined as at least a 15 point improvement in NDI Score at 24 months compared with baseline, maintenance or improvement in neurologic status at 24 months compared with baseline, no device failures or revision, reoperation, removal and/or supplemental fixation within 24 months; and the absence of major adverse events within 24 months. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.
Time frame: Baseline, 24 Months
Population: Success is presented on observed data only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Number of Participants With Composite Clinical Success (CCS) of Simplify Disc | 68 Participants |
| Simplify Disc | Number of Participants With Composite Clinical Success (CCS) of Simplify Disc | 132 Participants |
p-value: <0.001t-test, 1 sided
Secondary
Average Disc Height (Above the Index Level)
Change in average disc height (Above the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Average Disc Height (Above the Index Level) | -0.05 millimeters | Standard Deviation 0.4 |
| Simplify Disc | Average Disc Height (Above the Index Level) | 0 millimeters | Standard Deviation 0.23 |
Secondary
Average Disc Height (Below the Index Level)
Change in average disc height (below the index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Average Disc Height (Below the Index Level) | -0.07 millimeters | Standard Deviation 0.26 |
| Simplify Disc | Average Disc Height (Below the Index Level) | -0.07 millimeters | Standard Deviation 0.31 |
Secondary
Average Disc Height (Index Level)
Change in average disc height (index level) was compared to the baseline measurements and scored by an independent core lab (MMI). Average disc height is calculated as the simple average of the anterior and posterior disc heights.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Average Disc Height (Index Level) | 1.46 millimeters | Standard Deviation 1.24 |
| Simplify Disc | Average Disc Height (Index Level) | 0.93 millimeters | Standard Deviation 0.87 |
Secondary
Device Migration
Device migration assesses significant movement of the implant postoperatively
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | None | 90 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | Unable to assess | 5 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | Anterior | 0 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | Posterior | 0 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | Left | 0 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Device Migration | Right | 0 Participants |
| Simplify Disc | Device Migration | Left | 0 Participants |
| Simplify Disc | Device Migration | Posterior | 0 Participants |
| Simplify Disc | Device Migration | Unable to assess | 2 Participants |
| Simplify Disc | Device Migration | None | 137 Participants |
| Simplify Disc | Device Migration | Right | 0 Participants |
| Simplify Disc | Device Migration | Anterior | 0 Participants |
Secondary
Dysphagia Handicap Index (DHI)
Dysphagia Handicap Index (DHI scale) for the investigational Simplify® Disc at 24 months compared to baseline. A higher score is indicative of a less desirable outcome. It is scored 0-100. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Time frame: Baseline, 24 Months
Population: Data analyzed based on available 24-month DHI scores. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Dysphagia Handicap Index (DHI) | -2.3 score on a scale | Standard Deviation 8.6 |
Secondary
Facet Deterioration
Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24. Facet degeneration was not assessed in the ACDF historical control group, as there is no 24 month MRI. This was pre-specified in the study design.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Facet Deterioration | None | 80 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Facet Deterioration | Mild | 42 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Facet Deterioration | Moderate | 9 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Facet Deterioration | Severe | 1 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Facet Deterioration | Unable to Assess | 7 Participants |
Secondary
Inferior Adjacent Level Disc Degeneration
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Inferior Adjacent Level Disc Degeneration | Mild | 15 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Inferior Adjacent Level Disc Degeneration | Severe | 10 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Inferior Adjacent Level Disc Degeneration | Moderate | 23 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Inferior Adjacent Level Disc Degeneration | Unable to assess | 33 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Inferior Adjacent Level Disc Degeneration | None | 14 Participants |
| Simplify Disc | Inferior Adjacent Level Disc Degeneration | Unable to assess | 11 Participants |
| Simplify Disc | Inferior Adjacent Level Disc Degeneration | None | 95 Participants |
| Simplify Disc | Inferior Adjacent Level Disc Degeneration | Mild | 15 Participants |
| Simplify Disc | Inferior Adjacent Level Disc Degeneration | Moderate | 16 Participants |
| Simplify Disc | Inferior Adjacent Level Disc Degeneration | Severe | 2 Participants |
Secondary
Neurological Status
Neurological success was defined as maintenance or improvement in neurologic status at Month 24 as compared to baseline, as determined by the independent Clinical Events Committee (CEC). The CEC reviews neurological exams of motor, sensory, reflex, clumsiness, atrophy, cramping, spasms, numbness, dysphagia, dysphonia, and myelopathic gait to make an adjudication determination.
Time frame: Baseline, 24 Months
Population: Subjects were analyzed based on available 24-month data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Neurological Status | Maintained | 38 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Neurological Status | Deteriorated | 5 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Neurological Status | Improved | 52 Participants |
| Simplify Disc | Neurological Status | Improved | 111 Participants |
| Simplify Disc | Neurological Status | Maintained | 27 Participants |
| Simplify Disc | Neurological Status | Deteriorated | 1 Participants |
Secondary
Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery)
Time to recovery is defined as time to first 15-point improvement in NDI NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.
Time frame: Baseline, 3 Months
Population: Data is presented on available NDI scores.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) | 15-Point Improvement (Yes) | 90 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) | 15-Point Improvement (No) | 21 Participants |
| Simplify Disc | Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) | 15-Point Improvement (Yes) | 139 Participants |
| Simplify Disc | Number of Subjects With 15-point Improvement in NDI at 3 Months (Time to Recovery) | 15-Point Improvement (No) | 6 Participants |
Secondary
Odom's Criteria Results
Results at 24 months for the investigational Simplify® Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
Time frame: 24 Months
Population: Data presented on subject's with Odom's Criteria result at Month 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Odom's Criteria Results | Good | 18 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Odom's Criteria Results | Excellent | 64 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Odom's Criteria Results | Fair | 8 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Odom's Criteria Results | Poor | 5 Participants |
| Simplify Disc | Odom's Criteria Results | Poor | 1 Participants |
| Simplify Disc | Odom's Criteria Results | Fair | 5 Participants |
| Simplify Disc | Odom's Criteria Results | Excellent | 121 Participants |
| Simplify Disc | Odom's Criteria Results | Good | 12 Participants |
Secondary
Patient Questionnaires- Treatment Satisfaction Health Survey-
Question 1 - how does the subject rate satisfaction with the treated received was compared between groups at Month 24. Answer options ranged from very dissatisfied to very satisfied.
Time frame: 24 Months
Population: Presented data on available survey responses at Month 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Very Satisfied | 67 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Satisfied | 20 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Somewhat Satisfied | 5 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Somewhat Dissatisfied | 3 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Dissatisfied | 1 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Patient Questionnaires- Treatment Satisfaction Health Survey- | Very Dissatisfied | 0 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Dissatisfied | 0 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Very Satisfied | 122 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Somewhat Dissatisfied | 2 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Satisfied | 12 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Very Dissatisfied | 0 Participants |
| Simplify Disc | Patient Questionnaires- Treatment Satisfaction Health Survey- | Somewhat Satisfied | 2 Participants |
Secondary
SF-12 Mental Component Score (MCS) Maintenance or Improvement
The MCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Time frame: Baseline, 24 Months
Population: Subjects analyzed based on available data at month 24. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | SF-12 Mental Component Score (MCS) Maintenance or Improvement | Maintenance or Improvement | 105 Participants |
| Anterior cervical discectomy & fusion (ACDF) | SF-12 Mental Component Score (MCS) Maintenance or Improvement | Absence of Maintenance or Improvement | 33 Participants |
Secondary
SF-12 Physical Component Score (PCS) Maintenance or Improvement
The PCS is a sub-score of the SF-12. The SF-12 is a multipurpose short form survey with 12 questions all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related-quality of life. Higher scores indicate better outcomes. Scores range from 0-50. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Time frame: Baseline, 24 Months
Population: Subjects analyzed based on available data at month 24. Data was not collected on SF-12 in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | SF-12 Physical Component Score (PCS) Maintenance or Improvement | Maintenance or Improvement | 129 Participants |
| Anterior cervical discectomy & fusion (ACDF) | SF-12 Physical Component Score (PCS) Maintenance or Improvement | Absence of Maintenance or Improvement | 9 Participants |
Secondary
Superior Adjacent Level Disc Degeneration
Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level.
Time frame: Baseline, 24 Months
Population: Data presented on available images at Month 24
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Superior Adjacent Level Disc Degeneration | Mild | 22 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Superior Adjacent Level Disc Degeneration | Severe | 20 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Superior Adjacent Level Disc Degeneration | Moderate | 36 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Superior Adjacent Level Disc Degeneration | Unable to assess | 2 Participants |
| Anterior cervical discectomy & fusion (ACDF) | Superior Adjacent Level Disc Degeneration | None | 15 Participants |
| Simplify Disc | Superior Adjacent Level Disc Degeneration | Unable to assess | 3 Participants |
| Simplify Disc | Superior Adjacent Level Disc Degeneration | None | 87 Participants |
| Simplify Disc | Superior Adjacent Level Disc Degeneration | Mild | 26 Participants |
| Simplify Disc | Superior Adjacent Level Disc Degeneration | Moderate | 20 Participants |
| Simplify Disc | Superior Adjacent Level Disc Degeneration | Severe | 3 Participants |
Secondary
VAS Neck and Arm Pain
Changes of at least 20 mm on a 100mm will be regarded as clinically significant VAS 0mm (no pain); VAS 100mm (worst pain)
Time frame: Baseline, 24 Months
Population: Presented data available for comparison (preop and at month 24)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | VAS Neck and Arm Pain | Success | 83 Participants |
| Anterior cervical discectomy & fusion (ACDF) | VAS Neck and Arm Pain | Failure | 12 Participants |
| Simplify Disc | VAS Neck and Arm Pain | Success | 134 Participants |
| Simplify Disc | VAS Neck and Arm Pain | Failure | 5 Participants |