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study progress and recruitment rate too low
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The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
The protocol underwent 3 amendments, the last of which (02APR2009) changed the study design from a randomized to a non-randomized and non-comparative clinical trial. All of the subjects were enrolled under the randomized design with the exception of the last subject. This study is not applicable per FDAA Title VIII, Section 801 due to the final trial design. However, results are submitted to clinicaltrials.gov due to the majority of study data being collected under a randomized (FDAA Title VIII, Section 801 applicable) trial design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Cervical Discectomy and Fusion (ACDF) | Other | Anterior Cervical Discectomy and Fusion with Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft |
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| Cervical Total Disc Replacement | Active Comparator | DISCOVER™ Artificial Cervical Disc |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DISCOVER™ Artificial Cervical Disc | Device | DISCOVER™ Artificial Cervical Disc |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Patient Success | Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck. |
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Inclusion Criteria:
Male or female subjects, aged between 18 and 65 years inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following:
Unresponsive to documented non-surgical management for ≥ 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.)
Minimum Neck Disability Index score of ≥30 % (15/50 points)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Private Hospital | Sydney | New South Wales | Australia | |||
| Calvary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32049677 | Derived | Salmons HI, Galetta MS, Divi SN, Fried TB, Fang T, Hoffman E, Goyal DKC, Mangan JJ, Schroeder GD, Vaccaro AR. Are Industry-funded Studies of Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion Biased? Clin Spine Surg. 2021 Feb 1;34(1):1-3. doi: 10.1097/BSD.0000000000000946. No abstract available. |
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5 sites enrolled 60 subjects who were randomized into two treatment groups. Site 12 (17 subjects total) transferred into the Discover IDE study. Site 04 (5 subjects total) did not submit data, which was limited, due to EDC technical difficulties at the site. Therefore 38 subjects are reported in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Total Disc Replacement | DISCOVER Artificial Cervical Disc |
| FG001 | ACDF | Anterior Cervical Discectomy and Fusion (ACDF) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ACDF | Device | Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft |
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| 12 months |
| Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm. | 12 Months |
| Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm. | 12 Months |
| Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder. | 12 Months |
| Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder. | 12 Months |
| Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36) | 12 months |
| Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36) | 12 months |
| Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months | The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable. | 12 months |
| Work Status Assessed at 12 Months | The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval. | 12 months |
| Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months | Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view. | 6 months |
| Adjacent Level Degeneration Measured Radiographically at 24 Months | Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA. | 24 months |
| Maintenance of Disc Height Measured Radiographically at 6 Months | Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm). | 6 months |
| Foraminal Height Measured Radiographically at 24 Months | Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI). | 24 months |
| Cervical Range of Motion Measured Radiographically at 6 Months | Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs. | 6 months |
| Device Related Adverse Events | The proportion of subjects with device related adverse events as reported throughout the duration of the study. | Intra-operatively to 24 months post-operative |
| Tasmania |
| Australia |
| Klinikum Neustadt | Neustadt | Holstein | Germany |
| Divisione di Neurochirurgia | Rome | Italy |
| Island Hospital | George Town | Malaysia |
| Elisabeth Ziekenhuis | Tilburg | Netherlands |
| La Paz Hospital | Madrid | Spain |
| Hope Hospital | Manchester | Lancashire | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Total Disc Replacement | DISCOVER™ Artificial Cervical Disc |
| BG001 | ACDF | Anterior Cervical Discectomy and Fusion (ACDF) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Patient Success | Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized. | Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation. | Posted | Number | Percentage of subjects | 12 months |
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| Secondary | Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months. | The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder. | Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
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| Secondary | Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36) | Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36) | Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months | The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome. | Posted | Number | Percentage of Subjects | 12 months |
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| Secondary | Work Status Assessed at 12 Months | The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval. | Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome. | Posted | Number | Percentage of Subjects | 12 months |
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| Secondary | Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months | Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view. | Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis. | Posted | Mean | Standard Deviation | degrees | 6 months |
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| Secondary | Adjacent Level Degeneration Measured Radiographically at 24 Months | Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA. | Study was terminated prior to 24 months therefore there are no results for this endpoint. | Posted | 24 months |
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| Secondary | Maintenance of Disc Height Measured Radiographically at 6 Months | Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm). | Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis. | Posted | Mean | Standard Deviation | mm | 6 months |
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| Secondary | Foraminal Height Measured Radiographically at 24 Months | Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI). | The study was terminated prior to 24 months therefore there are no results for this endpoint. | Posted | 24 months |
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| Secondary | Cervical Range of Motion Measured Radiographically at 6 Months | Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs. | Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure. | Posted | Mean | Standard Deviation | degrees | 6 months |
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| Secondary | Device Related Adverse Events | The proportion of subjects with device related adverse events as reported throughout the duration of the study. | Posted | Number | Percentage of subjects | Intra-operatively to 24 months post-operative |
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Adverse Events were collected from the intra-operatively to 24 months post-operative timepoint (the patient with the longest follow-up for potential AE reporting was 24 months).
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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 | Cervical Total Disc Replacement | DISCOVER™ Artificial Cervical Disc | 3 | 22 | 9 | 22 | ||
| EG001 | ACDF | Anterior Cervical Discectomy and Fusion (ACDF) | 1 | 16 | 6 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Respiratory Tract Infections | Infections and infestations | MedDRA 16.0 |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA 16.0 |
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| Faecal Incontinence | Gastrointestinal disorders | MedDRA 16.0 |
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| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 |
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| Horner's Syndrome | Nervous system disorders | MedDRA 16.0 |
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| Paraesthesia | Nervous system disorders | MedDRA 16.0 |
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Study was terminated early therefore the latest clinical data available is at the 12 month post-operative timepoint and the latest radiographic data available is at the 6 month post-operative timepoint.
Clinical Investigators may freely present or publish results of the Clinical Investigation in a manner which fairly sets forth the conclusions reached by the Clinical Investigators, but only after DePuy has been given the opportunity of reviewing the proposed presentation or publication at least 30 days prior to the intended submission, presentation, or publication date.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lotito | DePuy Synthes Spine | (508) 880-8045 | Mlotito@its.jnj.com |
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