Symptomatic Cervical Disc Disease
Conditions
Keywords
ProDisc, ProDisc-C, Spinal Fusion, Anterior cervical diskectomy, Cervical spine, Disc disease, Implant, Degenerative disc disease, Intervertebral disc
Brief summary
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).
Interventions
DEVICETotal Disc Replacement
Total Disc Replacement using ProDisc-C
DEVICEACDF
Anterior Cervical Discectomy and Fusion
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height. * Age between 18 and 60 years. * Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment. * NDI score greater than or equal to 15/50 (30%). * Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms. * Signed informed consent.
Exclusion criteria
* More than one vertebral level requiring treatment. * Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level. * Has a fused level adjacent to the level to be treated. * Radiographic confirmation of severe facet joint disease or degeneration. * Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene. * Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion. * Prior surgery at the level to be treated. * Severe spondylosis at the level to be treated as characterized by any of the following: Bridging osteophytes; A loss of disc height greater than 50%; or Absence of motion (\<2°). * Neck or arm pain of unknown etiology. * Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis). * Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above). * Severe diabetes mellitus requiring daily insulin management. * Pregnant or interested in becoming pregnant in the next three years. * Active infection - systemic or local. * Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). * Rheumatoid arthritis or other autoimmune disease. * Systemic disease including AIDS, HIV, hepatitis. * Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success | 84 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NDI | 84 months | 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: * 0-4 points (0-8%) no disability; * 5-14 points (10-28%) mild disability; * 15-24 points (30-48%) moderate disability; * 25-34 points (50-64%) severe disability; * 35-50 points (70-100%) complete disability |
| SF-36 Physical Composite Score (PCS) | 84 Months | 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. |
| SF-36 Mental Composite Score (MCS) | 84 Months | 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. |
| VAS Satisfaction | 84 Months | 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. |
| Neurologic Success | 84 months | % 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) |
| VAS Neck Pain Frequency | 84 Months | 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. |
| VAS Arm Pain Intensity | 84 Months | 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. |
| VAS Arm Pain Frequency | 84 Months | 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. |
| Surgery Again | 84 Months | % of subjects who would opt to have the surgery again if given the choice at 84 months |
| VAS Neck Pain Intensity | 84 Months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| Control Anterior Cervical Discectomy and Fusion ACDF Randomized | 106 |
| 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 | 136 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 3 | 3 | 4 |
| Overall Study | Failures | 5 | 12 | 5 |
| Overall Study | Lost to Follow-up | 3 | 4 | 18 |
| Overall Study | Not Consented or Declined PAS | 12 | 15 | 15 |
| Overall Study | Withdrawal by Subject | 2 | 8 | 1 |
Baseline characteristics
| Characteristic | Control | Total | ProDisc-C | ProDisc-C Continued Access |
|---|---|---|---|---|
| Age, Continuous | 43.5 Years STANDARD_DEVIATION 7.15 | 43.1 Years STANDARD_DEVIATION 7.86 | 42.1 Years STANDARD_DEVIATION 8.42 | 43.4 Years STANDARD_DEVIATION 7.95 |
| BMI | 27.3 kg/m^2 STANDARD_DEVIATION 5.54 | 26.8 kg/m^2 STANDARD_DEVIATION 5.29 | 26.4 kg/m^2 STANDARD_DEVIATION 5.32 | 26.6 kg/m^2 STANDARD_DEVIATION 5.07 |
| Duration of Neck/Arm Pain > 1 year | 59 Subjects | 201 Subjects | 56 Subjects | 86 Subjects |
| Duration of Neck/Arm Pain < 6 weeks | 3 Subjects | 7 Subjects | 3 Subjects | 1 Subjects |
| Duration of Neck/Arm Pain 6 weeks to 1 year | 44 Subjects | 137 Subjects | 44 Subjects | 49 Subjects |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 10 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 97 Participants | 310 Participants | 88 Participants | 125 Participants |
| Region of Enrollment United States | 106 Participants | 345 Participants | 103 Participants | 136 Participants |
| Sex: Female, Male Female | 57 Participants | 192 Participants | 57 Participants | 78 Participants |
| Sex: Female, Male Male | 49 Participants | 153 Participants | 46 Participants | 58 Participants |
| Smoking Status Current | 37 Subjects | 98 Subjects | 34 Subjects | 27 Subjects |
| Smoking Status Former | 20 Subjects | 68 Subjects | 18 Subjects | 30 Subjects |
| Smoking Status Never | 49 Subjects | 179 Subjects | 51 Subjects | 79 Subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 98 / 103 | 100 / 106 | 121 / 136 |
| serious Total, serious adverse events | 45 / 103 | 53 / 106 | 58 / 136 |
Outcome results
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
Time frame: 84 Months
Population: Subjects with data at 84 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProDisc-C | Overall Success | 62.8 % of Subjects |
| Control | Overall Success | 53.2 % of Subjects |
| ProDisc-C Continued Access | Overall Success | 62.7 % of Subjects |
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: * 0-4 points (0-8%) no disability; * 5-14 points (10-28%) mild disability; * 15-24 points (30-48%) moderate disability; * 25-34 points (50-64%) severe disability; * 35-50 points (70-100%) complete disability
Time frame: 84 months
Population: Completed the NDI Questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | NDI | Significant Improvement (greater than 20% change) | 84.6 % of Subjects |
| ProDisc-C | NDI | Improvement (3% to 20% change) | 9.0 % of Subjects |
| ProDisc-C | NDI | No Change (-3% to 3% change) | 1.3 % of Subjects |
| ProDisc-C | NDI | Deterioration (less than -3% change) | 5.1 % of Subjects |
| Control | NDI | Deterioration (less than -3% change) | 6.3 % of Subjects |
| Control | NDI | Significant Improvement (greater than 20% change) | 84.4 % of Subjects |
| Control | NDI | No Change (-3% to 3% change) | 0.0 % of Subjects |
| Control | NDI | Improvement (3% to 20% change) | 9.4 % of Subjects |
| ProDisc-C Continued Access | NDI | Deterioration (less than -3% change) | 5.4 % of Subjects |
| ProDisc-C Continued Access | NDI | Improvement (3% to 20% change) | 9.7 % of Subjects |
| ProDisc-C Continued Access | NDI | No Change (-3% to 3% change) | 3.2 % of Subjects |
| ProDisc-C Continued Access | NDI | Significant Improvement (greater than 20% change) | 81.7 % of Subjects |
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)
Time frame: 84 months
Population: Subjects who were per protocol excluding device failures
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProDisc-C | Neurologic Success | 87.0 % of Subjects |
| Control | Neurologic Success | 89.1 % of Subjects |
| ProDisc-C Continued Access | Neurologic Success | 93.5 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the SF-36 questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | SF-36 Mental Composite Score (MCS) | Significant Improvement (>15% change) | 52.6 % of Subjects |
| ProDisc-C | SF-36 Mental Composite Score (MCS) | Improvement (3% to 15% change) | 19.2 % of Subjects |
| ProDisc-C | SF-36 Mental Composite Score (MCS) | No Change (-3% to 3% change) | 9.0 % of Subjects |
| ProDisc-C | SF-36 Mental Composite Score (MCS) | Deterioration (less than -3% change) | 19.2 % of Subjects |
| Control | SF-36 Mental Composite Score (MCS) | Deterioration (less than -3% change) | 24.2 % of Subjects |
| Control | SF-36 Mental Composite Score (MCS) | Significant Improvement (>15% change) | 50.0 % of Subjects |
| Control | SF-36 Mental Composite Score (MCS) | No Change (-3% to 3% change) | 3.2 % of Subjects |
| Control | SF-36 Mental Composite Score (MCS) | Improvement (3% to 15% change) | 22.6 % of Subjects |
| ProDisc-C Continued Access | SF-36 Mental Composite Score (MCS) | Deterioration (less than -3% change) | 18.9 % of Subjects |
| ProDisc-C Continued Access | SF-36 Mental Composite Score (MCS) | Improvement (3% to 15% change) | 21.1 % of Subjects |
| ProDisc-C Continued Access | SF-36 Mental Composite Score (MCS) | No Change (-3% to 3% change) | 5.6 % of Subjects |
| ProDisc-C Continued Access | SF-36 Mental Composite Score (MCS) | Significant Improvement (>15% change) | 54.4 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the SF-36 questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | SF-36 Physical Composite Score (PCS) | Significant Improvement (>15% change) | 78.2 % of Subjects |
| ProDisc-C | SF-36 Physical Composite Score (PCS) | Improvement (3% to 15% change) | 7.7 % of Subjects |
| ProDisc-C | SF-36 Physical Composite Score (PCS) | No Change (-3% to 3% change) | 2.6 % of Subjects |
| ProDisc-C | SF-36 Physical Composite Score (PCS) | Deterioration (less than -3% change) | 11.5 % of Subjects |
| Control | SF-36 Physical Composite Score (PCS) | Deterioration (less than -3% change) | 6.5 % of Subjects |
| Control | SF-36 Physical Composite Score (PCS) | Significant Improvement (>15% change) | 74.2 % of Subjects |
| Control | SF-36 Physical Composite Score (PCS) | No Change (-3% to 3% change) | 3.2 % of Subjects |
| Control | SF-36 Physical Composite Score (PCS) | Improvement (3% to 15% change) | 16.1 % of Subjects |
| ProDisc-C Continued Access | SF-36 Physical Composite Score (PCS) | Deterioration (less than -3% change) | 17.8 % of Subjects |
| ProDisc-C Continued Access | SF-36 Physical Composite Score (PCS) | Improvement (3% to 15% change) | 11.1 % of Subjects |
| ProDisc-C Continued Access | SF-36 Physical Composite Score (PCS) | No Change (-3% to 3% change) | 2.2 % of Subjects |
| ProDisc-C Continued Access | SF-36 Physical Composite Score (PCS) | Significant Improvement (>15% change) | 68.9 % of Subjects |
Secondary
Surgery Again
% of subjects who would opt to have the surgery again if given the choice at 84 months
Time frame: 84 Months
Population: Subjects who completed this questionnaire at 84 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | Surgery Again | Maybe | 6.4 % of Subjects |
| ProDisc-C | Surgery Again | Yes | 92.3 % of Subjects |
| ProDisc-C | Surgery Again | No | 1.3 % of Subjects |
| Control | Surgery Again | Maybe | 14.1 % of Subjects |
| Control | Surgery Again | Yes | 81.3 % of Subjects |
| Control | Surgery Again | No | 4.7 % of Subjects |
| ProDisc-C Continued Access | Surgery Again | Yes | 91.3 % of Subjects |
| ProDisc-C Continued Access | Surgery Again | No | 1.1 % of Subjects |
| ProDisc-C Continued Access | Surgery Again | Maybe | 7.6 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the VAS Arm Pain Frequency Questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | VAS Arm Pain Frequency | Significant Improvement (more than -20mm change) | 61.5 % of Subjects |
| ProDisc-C | VAS Arm Pain Frequency | Improvement (-3mm to -20mm change) | 21.8 % of Subjects |
| ProDisc-C | VAS Arm Pain Frequency | No Change (-3mm to 3mm change) | 10.3 % of Subjects |
| ProDisc-C | VAS Arm Pain Frequency | Deterioration (more than 3mm) | 6.4 % of Subjects |
| Control | VAS Arm Pain Frequency | Deterioration (more than 3mm) | 8.2 % of Subjects |
| Control | VAS Arm Pain Frequency | Significant Improvement (more than -20mm change) | 75.4 % of Subjects |
| Control | VAS Arm Pain Frequency | No Change (-3mm to 3mm change) | 8.2 % of Subjects |
| Control | VAS Arm Pain Frequency | Improvement (-3mm to -20mm change) | 8.2 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Frequency | Deterioration (more than 3mm) | 10.8 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Frequency | Improvement (-3mm to -20mm change) | 15.1 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Frequency | No Change (-3mm to 3mm change) | 7.5 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Frequency | Significant Improvement (more than -20mm change) | 66.7 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the VAS Arm Pain Intensity Questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | VAS Arm Pain Intensity | Significant Improvement (more than -20mm change) | 66.7 % of Subjects |
| ProDisc-C | VAS Arm Pain Intensity | Improvement (-3mm to -20mm change) | 16.7 % of Subjects |
| ProDisc-C | VAS Arm Pain Intensity | No Change (-3mm to 3mm change) | 7.7 % of Subjects |
| ProDisc-C | VAS Arm Pain Intensity | Deterioration (more than 3mm) | 9.0 % of Subjects |
| Control | VAS Arm Pain Intensity | Deterioration (more than 3mm) | 11.3 % of Subjects |
| Control | VAS Arm Pain Intensity | Significant Improvement (more than -20mm change) | 74.2 % of Subjects |
| Control | VAS Arm Pain Intensity | No Change (-3mm to 3mm change) | 4.8 % of Subjects |
| Control | VAS Arm Pain Intensity | Improvement (-3mm to -20mm change) | 9.7 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Intensity | Deterioration (more than 3mm) | 9.7 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Intensity | Improvement (-3mm to -20mm change) | 15.1 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Intensity | No Change (-3mm to 3mm change) | 6.5 % of Subjects |
| ProDisc-C Continued Access | VAS Arm Pain Intensity | Significant Improvement (more than -20mm change) | 68.8 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the VAS Neck Pain Frequency Questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | VAS Neck Pain Frequency | Significant Improvement (more than -20mm change) | 78.2 % of Subjects |
| ProDisc-C | VAS Neck Pain Frequency | Improvement (-3mm to -20mm change) | 10.3 % of Subjects |
| ProDisc-C | VAS Neck Pain Frequency | No Change (-3mm to 3mm change) | 9.0 % of Subjects |
| ProDisc-C | VAS Neck Pain Frequency | Deterioration (more than 3mm) | 2.6 % of Subjects |
| Control | VAS Neck Pain Frequency | Deterioration (more than 3mm) | 11.3 % of Subjects |
| Control | VAS Neck Pain Frequency | Significant Improvement (more than -20mm change) | 74.2 % of Subjects |
| Control | VAS Neck Pain Frequency | No Change (-3mm to 3mm change) | 3.2 % of Subjects |
| Control | VAS Neck Pain Frequency | Improvement (-3mm to -20mm change) | 11.3 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Frequency | Deterioration (more than 3mm) | 10.8 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Frequency | Improvement (-3mm to -20mm change) | 12.9 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Frequency | No Change (-3mm to 3mm change) | 3.2 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Frequency | Significant Improvement (more than -20mm change) | 73.1 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the VAS Neck Pain Intensity Questionnaire at 84 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProDisc-C | VAS Neck Pain Intensity | Significant Improvement (more than -20mm change) | 76.9 % of Subjects |
| ProDisc-C | VAS Neck Pain Intensity | Improvement (-3mm to -20mm change) | 10.3 % of Subjects |
| ProDisc-C | VAS Neck Pain Intensity | No Change (-3mm to 3mm change) | 5.1 % of Subjects |
| ProDisc-C | VAS Neck Pain Intensity | Deterioration (more than 3mm) | 7.7 % of Subjects |
| Control | VAS Neck Pain Intensity | Deterioration (more than 3mm) | 8.1 % of Subjects |
| Control | VAS Neck Pain Intensity | Significant Improvement (more than -20mm change) | 72.6 % of Subjects |
| Control | VAS Neck Pain Intensity | No Change (-3mm to 3mm change) | 4.8 % of Subjects |
| Control | VAS Neck Pain Intensity | Improvement (-3mm to -20mm change) | 14.5 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Intensity | Deterioration (more than 3mm) | 2.2 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Intensity | Improvement (-3mm to -20mm change) | 17.2 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Intensity | No Change (-3mm to 3mm change) | 2.2 % of Subjects |
| ProDisc-C Continued Access | VAS Neck Pain Intensity | Significant Improvement (more than -20mm change) | 78.5 % of Subjects |
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.
Time frame: 84 Months
Population: Subjects who completed the VAS Satisfaction Questionnaire at 84 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProDisc-C | VAS Satisfaction | 86.16 | Standard Deviation 23.75 |
| Control | VAS Satisfaction | 82.09 | Standard Deviation 29.331 |
| ProDisc-C Continued Access | VAS Satisfaction | 86.51 | Standard Deviation 23.531 |