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This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.
The objective of this clinical study is to evaluate the safety and effectiveness of the two-level Simplify® Disc compared to conventional two-level ACDF in skeletally mature patients for reconstruction of two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces that are unresponsive to conservative management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplify Disc | Experimental | Simplify Disc at two levels of the cervical spine |
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| Historical Control | No Intervention | 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 of a previously completed two level cervical disc trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplify Disc | Device | Simplify Disc at two levels of the cervical spine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Clinical Success (CCS) Rate of the Simplify® Disc | Individual success 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 additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated 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. | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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, and myelopathic gait to make an adjudication determination. | Baseline, 24mos |
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Inclusion Criteria:
Exclusion Criteria:
Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
Has more than two cervical levels requiring surgical treatment;
Has a fused level (or artificial disc replacement) adjacent to the levels to be treated;
Has severe pathology of the facet joints of the involved vertebral bodies;
Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels;
Axial neck pain only (no radicular or myelopathy symptoms);
Has been previously diagnosed with osteopenia or osteomalacia;
Has any of the following that may be associated with a diagnosis of osteoporosis (if "Yes" to any of the below risk factors, a DEXA Scan will be required to determine eligibility):
Has presence of spinal metastases;
Has overt or active bacterial infection, either local or systemic;
Has insulin-dependent diabetes;
Has chronic or acute renal failure or prior history of renal disease;
Known PEEK, ceramic, titanium allergy;
Is mentally incompetent (if questionable, obtain psychiatric consult);
Is a prisoner;
Is pregnant;
Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
Is involved with current or pending litigation regarding a spinal condition;
Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs);
Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone | NuVasive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Education and Research Institute of Southern California | Orange | California | 92868 | United States | ||
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| Label | URL |
|---|---|
| Simplify Medical Website for the Simplify Disc Trial | View source |
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Historical control was used for control arm. The only subjects enrolled under this study were investigational subjects (Simplify Disc).
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| ID | Title | Description |
|---|---|---|
| FG000 | Simplify Disc | Simplify Disc at two levels of the cervical spine Simplify Disc: Simplify Disc at two levels of the cervical spine |
| FG001 | Historical Control - Anterior Cervical Discectomy and Fusion (ACDF) |
| 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 | Jul 15, 2021 |
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| 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, 3mos |
| Neck Pain Intensity Questionnaire | Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain) | Baseline, 24mos. |
| Arm Pain Intensity Questionnaire | Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain) | Baseline, 24mos. |
| Patient Questionnaires- Treatment Satisfaction Survey | Question 1 - "I am satisfied with the results of my surgery" was compared between groups at Month 24. Answer options ranged from definitely true to definitely false. | Baseline, 24mos. |
| SF-36v2 Health Survey Physical Component Score (PCS) Maintenance or Improvement | The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. 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. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0. | Baseline, 24mos |
| SF-36 Mental Component Score (MCS) Maintenance or Improvement | The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. 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. Maintenance or improvement was defined as MCS(Postop) - MCS(Preop) ≥0. | Baseline, 24mos. |
| 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, 24mos. |
| Physician's Perception of 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 their perception of the results. Available responses include excellent, good, fair, and poor. Maintenance or improvement was defined as either maintenance of the assigned preoperative grade or any shift to a more favorable grade postoperatively (e.g. poor to fair, fair to good). | Baseline, 24mos. |
| Change in Average Disc Height (Superior Index Level) | Average disc height (superior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights. Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | Baseline, 24mos. |
| Change in Average Disc Height (Inferior Index Level) | Average disc height (inferior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights. Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | Baseline, 24M |
| Superior Adjacent Level Disc Degeneration (ALDD) | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess. Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | Baseline, 24mos. |
| Inferior Adjacent Level Disc Degeneration (ALDD) | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess. Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | Baseline, 24mos. |
| Facet Degeneration (Superior Index Level) | Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess. 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, 24mos. |
| Facet Degeneration (Inferior Index Level) | Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess. 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, 24mos. |
| The Spine Institute for Spine Restoration |
| Santa Monica |
| California |
| 90403 |
| United States |
| Spine Education and Research Foundation | Thornton | Colorado | 80229 | United States |
| Connecticut Orthopaedic Specialists | Hamden | Connecticut | 06518 | United States |
| Kennedy-White orthopedic Center | Sarasota | Florida | 34232 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42003 | United States |
| Spine institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Buffalo Spine Surgery | Lockport | New York | 14094 | United States |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Oregon Neurosurgery | Springfield | Oregon | 97477 | United States |
| Texas Spine Consultants | Addison | Texas | 75001 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| The Disc Replacement Center | West Jordan | Utah | 84088 | United States |
| Virginia Spine Institute | Reston | Virginia | 20191 | United States |
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 of a previously completed two level cervical disc trial.
| COMPLETED |
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| NOT COMPLETED |
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One hundred eighty-two (182) subjects were enrolled in the Simplify® Cervical Artificial Disc analysis population. An additional 18 Simplify® Cervical Artificial Disc subjects were training subjects and were not included in the analysis. The historical ACDF control analysis population included 170 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simplify Disc | Simplify Disc at two levels of the cervical spine Simplify Disc: Simplify Disc at two levels of the cervical spine |
| BG001 | Historical Control | 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 of a previously completed two level cervical disc trial. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity data not captured for historical control group. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Composite Clinical Success (CCS) Rate of the Simplify® Disc | Individual success 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 additional surgical procedure at the index level within 24 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated 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. | While 168 Simplify Disc subjects and 127 historical control subjects were considered completers for subject accounting purposes, 173 (Simplify Disc) and 145 (ACDF) subjects were evaluable for composite clinical success. This is due to the fact that some subjects were known failures prior to the 24-month visit. | Posted | Count of Participants | Participants | 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, and myelopathic gait to make an adjudication determination. | While 127 historical control subjects were considered completers for subject accounting purposes, 128 historical subjects had sufficient neurological data available for CEC determination of maintenance or improvement of neurological status. | Posted | Count of Participants | Participants | Baseline, 24mos |
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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. | While 168 Simplify Disc subjects and 127 historical control subjects were considered completers for subject accounting purposes at 24 months, 177 (Simplify Disc) and 154 (ACDF) subjects had evaluable change in NDI scores at 3 months. | Posted | Count of Participants | Participants | Baseline, 3mos |
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| Secondary | Neck Pain Intensity Questionnaire | Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain) | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 158 Simplify Disc subjects had change in Neck Pain Intensity data at 24 months due to missed questionnaires. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Arm Pain Intensity Questionnaire | Changes of at least 2 points on a 10-point scale will be regarded as clinically significant (0=no pain; 10=worst pain) | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 158 Simplify Disc subjects had change in Arm Pain Intensity data at 24 months due to missed questionnaires. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Patient Questionnaires- Treatment Satisfaction Survey | Question 1 - "I am satisfied with the results of my surgery" was compared between groups at Month 24. Answer options ranged from definitely true to definitely false. | While 168 Simplify Disc subjects and 127 historical control subjects were considered completers for subject accounting purposes, 172 (Simplify Disc) and 145 (ACDF) subjects had evaluable treatment satisfaction data at 24 months. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | SF-36v2 Health Survey Physical Component Score (PCS) Maintenance or Improvement | The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. 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. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 158 Simplify Disc subjects had SF-36 data available at 24 months due to missed questionnaires. | Posted | Count of Participants | Participants | Baseline, 24mos |
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| Secondary | SF-36 Mental Component Score (MCS) Maintenance or Improvement | The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. 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. Maintenance or improvement was defined as MCS(Postop) - MCS(Preop) ≥0. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 158 Simplify Disc subjects had SF-36 data available at 24 months due to missed questionnaires. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24mos. |
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| Secondary | Physician's Perception of 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 their perception of the results. Available responses include excellent, good, fair, and poor. Maintenance or improvement was defined as either maintenance of the assigned preoperative grade or any shift to a more favorable grade postoperatively (e.g. poor to fair, fair to good). | While 168 Simplify Disc subjects and 127 historical control subjects were considered completers for subject accounting purposes, 170 (Simplify Disc) and 145 (ACDF) subjects had evaluable Physician's Perception of Results data at 24 months. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Change in Average Disc Height (Superior Index Level) | Average disc height (superior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights. Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 164 Simplify Disc subjects had evaluable radiographs for this assessment at 24 months due to missed x-rays or poor image quality which limited analysis. | Posted | Mean | Standard Deviation | mm | Baseline, 24mos. |
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| Secondary | Change in Average Disc Height (Inferior Index Level) | Average disc height (inferior index level) at 24 months was compared to the baseline measurement and the change was calculated. Measurements were scored by an independent core lab. Average disc height is calculated as the simple average of the anterior and posterior disc heights. Data was not collected on disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 157 Simplify Disc subjects had evaluable radiographs for this assessment at 24 months due to missed x-rays or poor image quality which limited analysis. | Posted | Mean | Standard Deviation | mm | Baseline, 24M |
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| Secondary | Superior Adjacent Level Disc Degeneration (ALDD) | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess. Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 166 Simplify Disc subjects had evaluable radiographs for this assessment at 24 months due to missed x-rays or poor image quality which limited analysis. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Inferior Adjacent Level Disc Degeneration (ALDD) | Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space), indeterminate, or unable to assess. Data was not collected on ALDD in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 166 Simplify Disc subjects had evaluable radiographs for this assessment at 24 months due to missed x-rays or poor image quality which limited analysis. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Facet Degeneration (Superior Index Level) | Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess. 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. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 166 Simplify Disc subjects had an evaluable MRI for this assessment at 24 months due to missed MRIs. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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| Secondary | Facet Degeneration (Inferior Index Level) | Facet degeneration was assessed using MRI for the investigational Simplify Disc at 24 months compared to baseline. Degeneration was graded as none (normal facet joint space), mild (narrowing of the facet joint space and / or small osteophytes and / or mild hypertrophy of the articular process), moderate (narrowing of the facet joint space and/or moderate osteophytes and/or moderate hypertrophy of the articular process and / or mild subarticular bone erosions), severe (Narrowing of the facet joint space and/or large osteophytes and/or severe hypertrophy of the articular process and/or severe subarticular bone erosions and/or subchondral cysts), indeterminate, or unable to assess. 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. | While 168 Simplify Disc subjects were considered completers for subject accounting purposes, 166 Simplify Disc subjects had an evaluable MRI for this assessment at 24 months due to missed MRIs. | Posted | Count of Participants | Participants | Baseline, 24mos. |
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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 | Simplify Disc | Simplify Disc at two levels of the cervical spine Simplify Disc: Simplify Disc at two levels of the cervical spine | 2 | 182 | 32 | 182 | 96 | 182 |
| EG001 | Historical Control - Anterior Cervical Discectomy and Fusion (ACDF) | 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=188) of a previously completed two level cervical disc trial. | 1 | 170 | 62 | 170 | 145 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism | Vascular disorders | Systematic Assessment |
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| Infection (all other infections-NOT at cervical surgical site) | Infections and infestations | Systematic Assessment |
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| Hematoma or seroma | Vascular disorders | Systematic Assessment |
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| Accidental trauma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Low back pain (no narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Appendicular arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cervical Radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar Radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain (no narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vertebral fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Other | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal complications including ileus, nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Blood loss (greater than 500ml) | 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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| Difficulty with urination | Renal and urinary disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Pain (narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cerebrospinal fluid leakage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Development of DDD at adjacent levels | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dural injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Psychological Illness | Psychiatric disorders | Systematic Assessment |
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| Soft tissue damage | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dermatitis/Skin allergy | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Low back pain (narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Renal dysfunction | Renal and urinary disorders | Systematic Assessment |
| ||
| Nonunion/pseudoarthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Inflammation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Implant collapse or subsidence | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Spondylosis acquista | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Other | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Other | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cardiac Event | Cardiac disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection (all other infections-NOT at cervical surgical site) | Infections and infestations | Systematic Assessment |
| ||
| Accidental trauma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dermatitis/Skin allergy | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Low back pain (narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Appendicular arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cervical Radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Inflammation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lumbar Radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Numbness - increased from pre-op or prior visit | Nervous system disorders | Systematic Assessment |
| ||
| Pain (no narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Compressive Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Gastrointestinal complications including ileus, nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Development of DDD at adjacent levels | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Pain (narcotic given) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
ACDF data is presented as a historical control fusion group from a previously completed IDE trial.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Fulwider | NuVasive, Inc. | 7037721455 | jfulwider@nuvasive.com |
| Oct 12, 2022 |
| Prot_SAP_000.pdf |
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