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The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProDisc-C | Experimental | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 |
|
| Control | Active Comparator | ACDF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Disc Replacement | Device | Total Disc Replacement using ProDisc-C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success | Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material | 84 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurologic Success | % of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value) | 84 months |
| NDI |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23138404 | Derived | Mancuso CA, Cammisa FP, Sama AA, Hughes AP, Girardi FP. Development of an expectations survey for patients undergoing cervical spine surgery. Spine (Phila Pa 1976). 2013 Apr 20;38(9):718-25. doi: 10.1097/BRS.0b013e31827bf204. | |
| 23080427 | Derived | Zigler JE, Delamarter R, Murrey D, Spivak J, Janssen M. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976). 2013 Feb 1;38(3):203-9. doi: 10.1097/BRS.0b013e318278eb38. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ProDisc-C | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group |
| FG001 | Control | Anterior Cervical Discectomy and Fusion ACDF Randomized Group |
| FG002 | ProDisc-C Continued Access | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of subjects enrolled and treated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ProDisc-C | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized |
| BG001 | Control | Anterior Cervical Discectomy and Fusion ACDF Randomized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Success | Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material | Subjects with data at 84 months | Posted | Number | % of Subjects | 84 Months |
|
84 Months (i.e. 7 years)
All adverse events were captured from time of consent through the end of study (i.e. 84 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 | ProDisc-C | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Randomized Group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - Back and Lower Extremities | Nervous system disorders | Syncode | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain - Neck | Nervous system disorders | Syncode | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Prifogle | DePuy Synthes Spine | 508-977-6451 | eprifog1@its.jnj.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D059145 | Total Disc Replacement |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| ACDF | Device | Anterior Cervical Discectomy and Fusion |
|
|
NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain.
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation.
Mean duration of the test is 3-8 minutes and the results can be interpreted as:
| 84 months |
| SF-36 Physical Composite Score (PCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions. | 84 Months |
| SF-36 Mental Composite Score (MCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions. | 84 Months |
| VAS Satisfaction | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction [with the surgery/outcome]" at 0mm and "Complete Satisfaction [with the surgery/outcome]" at 100mm. | 84 Months |
| VAS Neck Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Neck] Pain" at 0mm and "Worst [Neck] Pain Possible" at 100mm. | 84 Months |
| VAS Neck Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Neck] Pain" at 0mm and "All of the Time [Neck] Pain" at 100mm. | 84 Months |
| VAS Arm Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Arm] Pain" at 0mm and "Worst [Arm] Pain Possible" at 100mm. | 84 Months |
| VAS Arm Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Arm] Pain" at 0mm and "All of the Time [Arm] Pain" at 100mm. | 84 Months |
| Surgery Again | % of subjects who would opt to have the surgery again if given the choice at 84 months | 84 Months |
| Withdrawal by Subject |
|
| Failures |
|
| Lost to Follow-up |
|
| BG002 | ProDisc-C Continued Access | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | number of subjects who are female or male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Smoking Status | Number | Subjects |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Duration of Neck/Arm Pain | Number | Subjects |
|
| Control |
Anterior Cervical Discectomy and Fusion ACDF Randomized |
| OG002 | ProDisc-C Continued Access | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized |
|
|
| Secondary | Neurologic Success | % of subjects who were a neurological success (i.e. the patient's neurologic parameters, i.e. motor, sensory, and reflexes are maintained or improved as compared to preoperative baseline value) | Subjects who were "per protocol" excluding device failures | Posted | Number | % of Subjects | 84 months |
|
|
|
| Secondary | NDI | NDI is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation and is the most commonly used self-report measure for neck pain. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0-5 rating scale (0='No pain' and 5='Worst imaginable pain'). The points can be summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage: 0 points or 0% means no activity limitations, 50 points or 100% means complete activity limitation. Mean duration of the test is 3-8 minutes and the results can be interpreted as:
| Completed the NDI Questionnaire at 84 Months | Posted | Number | % of Subjects | 84 months |
|
|
|
| Secondary | SF-36 Physical Composite Score (PCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Physical Composite Score (PCS) specifically looks at the mean average of all of the physically relevant questions. | Subjects who completed the SF-36 questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | SF-36 Mental Composite Score (MCS) | The Short form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF-36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. It can take patients at least half an hour to complete the SF-36. The Mental Composite Score (MCS) specifically looks at the mean average of all of the mental or emotional relevant questions. | Subjects who completed the SF-36 questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | VAS Satisfaction | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No Satisfaction [with the surgery/outcome]" at 0mm and "Complete Satisfaction [with the surgery/outcome]" at 100mm. | Subjects who completed the VAS Satisfaction Questionnaire at 84 Months | Posted | Mean | Standard Deviation | 84 Months |
|
|
|
| Secondary | VAS Neck Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Neck] Pain" at 0mm and "Worst [Neck] Pain Possible" at 100mm. | Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | VAS Neck Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Neck] Pain" at 0mm and "All of the Time [Neck] Pain" at 100mm. | Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | VAS Arm Pain Intensity | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "No [Arm] Pain" at 0mm and "Worst [Arm] Pain Possible" at 100mm. | Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | VAS Arm Pain Frequency | The Visual Analog Scale (VAS) is a commonly used questionnaire and is presented as a 100mm horizontal line. A patient represents their personal opinion regarding their health by adding a vertical line on the VAS horizontal line between the extremes of "None of the Time [Arm] Pain" at 0mm and "All of the Time [Arm] Pain" at 100mm. | Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| Secondary | Surgery Again | % of subjects who would opt to have the surgery again if given the choice at 84 months | Subjects who completed this questionnaire at 84 months | Posted | Number | % of Subjects | 84 Months |
|
|
|
| 45 |
| 103 |
| 98 |
| 103 |
| EG001 | Control | Anterior Cervical Discectomy and Fusion ACDF Randomized Group | 53 | 106 | 100 | 106 |
| EG002 | ProDisc-C Continued Access | ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7 Total Disc Replacement Non-Randomized Group | 58 | 136 | 121 | 136 |
| Pain - Shoulder | Nervous system disorders | Syncode | Systematic Assessment |
|
| Surgery - Index Level | Surgical and medical procedures | Syncode | Systematic Assessment | Surgery at the original index level of the cervical spine |
|
| Surgery - Other | Surgical and medical procedures | Syncode | Systematic Assessment | Surgery not at the index (cervical level) |
|
| Gastrointestinal | Gastrointestinal disorders | Syncode | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Syncode | Systematic Assessment |
|
| Pain - Back | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Neck and Upper Extremities | Nervous system disorders | Syncode | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Syncode | Systematic Assessment |
|
| Death | General disorders | Syncode | Systematic Assessment |
|
| Pain - Neck | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Other | Nervous system disorders | Syncode | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Syncode | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Syncode | Systematic Assessment |
|
| Headaches | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Back | Nervous system disorders | Syncode | Systematic Assessment |
|
| Surgery - Other | Surgical and medical procedures | Syncode | Systematic Assessment | Surgery not at the index (cervical) level |
|
| Pain - Shoulder | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Upper Extremities | Nervous system disorders | Syncode | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Syncode | Systematic Assessment |
|
| Neurological | Psychiatric disorders | Syncode | Systematic Assessment |
|
| Other | General disorders | Syncode | Systematic Assessment |
|
| Numbness Non-Index Level Related | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Back and Lower Extremities | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Other | Nervous system disorders | Syncode | Systematic Assessment |
|
| Dysphagia | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Neck and Upper Extremities with Numbness | Nervous system disorders | Syncode | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Syncode | Systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Syncode | Systematic Assessment |
|
| Insomnia | General disorders | Syncode | Systematic Assessment |
|
| Pain - Neck and Shoulder | Nervous system disorders | Syncode | Systematic Assessment |
|
| Pain - Neck and Upper Extremities | Nervous system disorders | Syncode | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Syncode | Systematic Assessment |
|
| Infection - Other Non-Wound Related | Infections and infestations | Syncode | Systematic Assessment |
|
| Pain - Upper Extremities with Numbness | Nervous system disorders | Syncode | Systematic Assessment |
|
| Musculoskeletal Spasms - Neck | Musculoskeletal and connective tissue disorders | Syncode | Systematic Assessment |
|
| Psychological | Psychiatric disorders | Syncode | Systematic Assessment |
|
| Surgery - Index Level | Surgical and medical procedures | Syncode | Systematic Assessment | Surgery at the index level (cervical) |
|
Not provided
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
|
| No Change (-3% to 3% change) |
|
| Deterioration (less than -3% change) |
|
|
| No Change (-3% to 3% change) |
|
| Deterioration (less than -3% change) |
|
|
| No Change (-3% to 3% change) |
|
| Deterioration (less than -3% change) |
|
|
| No Change (-3mm to 3mm change) |
|
| Deterioration (more than 3mm) |
|
|
| No Change (-3mm to 3mm change) |
|
| Deterioration (more than 3mm) |
|
|
| No Change (-3mm to 3mm change) |
|
| Deterioration (more than 3mm) |
|
|
| No Change (-3mm to 3mm change) |
|
| Deterioration (more than 3mm) |
|
| Title | Measurements |
|---|---|
|
| No |
|