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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior cervical discectomy & fusion (ACDF) | Other |
| |
| Simplify Disc | Experimental | Simplify Disc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplify Disc | Device | Simplify Disc at one level in the cervical spine. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 Months |
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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;
Have at least one of the following radiculopathy or myelopathy symptoms in neck and/or arm;
Have at least one of the following:
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;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | United States | ||||
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This is a non-randomized study. The 117 ACDF subjects are a historical control group. (Kineflex C Study; NCT#00374413)
Subjects were recruited across 16 clinical sites in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2022 |
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| Anterior Cervical Discectomy & Fusion |
| Device |
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. |
|
|
| 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) |
| Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| 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. | 24 Months |
| 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. | 24 Months |
| 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. | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| Superior Adjacent Level Disc Degeneration | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level. | Baseline, 24 Months |
| Inferior Adjacent Level Disc Degeneration | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level. | Baseline, 24 Months |
| Device Migration | Device migration assesses significant movement of the implant postoperatively | Baseline, 24 Months |
| 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. | Baseline, 24 Months |
| Orange |
| California |
| United States |
| Santa Monica | California | United States |
| Thornton | Colorado | United States |
| Sarasota | Florida | United States |
| Evanston | Illinois | United States |
| Carmel | Indiana | United States |
| Paducah | Kentucky | United States |
| Shreveport | Louisiana | United States |
| Egg Harbor | New Jersey | United States |
| Lockport | New York | United States |
| Charlotte | North Carolina | United States |
| Addison | Texas | United States |
| Plano | Texas | United States |
| Tyler | Texas | United States |
| Reston | Virginia | United States |
| Simplify Disc |
Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine. |
| COMPLETED |
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| NOT COMPLETED |
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One hundred sixty-six (166) subjects were enrolled in the Simplify® Cervical Artificial Disc population. Of these, 16 Simplify® Cervical Artificial Disc subjects were training subjects. The historical ACDF control population included 133 subjects. Of these, 117 control subjects were retained in the final PS designed sample
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Simplify Disc | Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Success is presented on observed data only | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | Data is presented on available NDI scores. | Posted | Count of Participants | Participants | Baseline, 3 Months |
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| 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) | Presented data available for comparison (preop and at month 24) | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | Subjects were analyzed based on available 24-month data. | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | Presented data on available survey responses at Month 24 | Posted | Count of Participants | Participants | 24 Months |
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| 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. | Data presented on subject's with Odom's Criteria result at Month 24 | Posted | Count of Participants | Participants | 24 Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 Months |
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| 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. | Data presented on available images at Month 24 | Posted | Mean | Standard Deviation | millimeters | Baseline, 24 Months |
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| 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. | Data presented on available images at Month 24 | Posted | Mean | Standard Deviation | millimeters | Baseline, 24 Months |
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| 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. | Data presented on available images at Month 24 | Posted | Mean | Standard Deviation | millimeters | Baseline, 24 Months |
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| Secondary | Superior Adjacent Level Disc Degeneration | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level. | Data presented on available images at Month 24 | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| Secondary | Inferior Adjacent Level Disc Degeneration | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level. | Data presented on available images at Month 24 | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| Secondary | Device Migration | Device migration assesses significant movement of the implant postoperatively | Data presented on available images at Month 24 | Posted | Count of Participants | Participants | Baseline, 24 Months |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, 24 Months |
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Adverse events were collected continuously throughout study follow-up period. Results are reported through study day 790.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial. | 0 | 117 | 16 | 117 | 65 | 117 |
| EG001 | Simplify Disc | Simplify Disc Simplify Disc: Simplify Disc at one level in the cervical spine. | 0 | 150 | 17 | 150 | 89 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections (all other infections - NOT at cervical surgical site) | Infections and infestations | Systematic Assessment |
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| Pseduoarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Psychological Illness | Psychiatric disorders | Systematic Assessment |
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| Pain (narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Adjacent Segment Degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Surgery at a location other than the spine | Surgical and medical procedures | Systematic Assessment |
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| Gastrointestinal Complications | Gastrointestinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Inflammation Conditions | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Esophageal Perforation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Infection; localized to cervical surgical site | Infections and infestations | Systematic Assessment |
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| Ischemia | Cardiac disorders | Systematic Assessment |
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| Deep wound infection; localized to cervical surgical site | Infections and infestations | Systematic Assessment |
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| Implant Collapse or Subsidence | Product Issues | Systematic Assessment |
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| Pain (No Narcotic Given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
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| Other | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Infections (All other infections NOT at cervical surgical site) | Infections and infestations | Systematic Assessment |
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| Inflammation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Adjacent Segment Degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | Systematic Assessment |
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| Pain (No narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Compressive Neuropathy | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Pain (Narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| GI Complications | Gastrointestinal disorders | Systematic Assessment |
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ACDF data is presented as a historical control fusion group from the Kineflex®|C Disc trial
Publication results vary per investigator and per clinical trial agreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Czaplewski | NuVasive, Inc. | 308-660-2021 | nczaplewski@nuvasive.com |
| Apr 4, 2022 |
| Prot_SAP_000.pdf |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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