An interventional study of Total Disc Replacement and ACDF in Symptomatic Cervical Disc Disease, sponsored by Synthes USA HQ, Inc.. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by Synthes USA HQ, Inc. · Not applicable, Interventional, and Treatment
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).
267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.
This study's enrollment of 368 is above the median of 52 across 166 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Synthes USA HQ, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
Device: Total Disc Replacement
ACDF
Device: ACDF
Total Disc Replacement using ProDisc-C
Also known as: ProDisc-C
Anterior Cervical Discectomy and Fusion
Also known as: Control
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
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
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
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
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
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
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
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
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
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
Surgery Again
% of subjects who would opt to have the surgery again if given the choice at 84 months
Time frame: 84 Months
| Milestone | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Started | 103 | 106 | 136 |
| Evaluated at 24 months | 99 | 92 | 105 |
| Completed | 78 | 64 | 93 |
| Not completed | 25 | 42 | 43 |
| Withdrew: Not consented or declined pas | 12 | 15 | 15 |
| Withdrew: Death | 3 | 3 | 4 |
| Withdrew: Withdrawal by subject | 2 | 8 | 1 |
| Withdrew: Failures | 5 | 12 | 5 |
| Withdrew: Lost to follow-up | 3 | 4 | 18 |
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
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Overall Success | 62.8 | 53.2 | 62.7 |
% 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)
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Neurologic Success | 87.0 | 89.1 | 93.5 |
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
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (greater than 20% change) | 84.6 | 84.4 | 81.7 |
| Improvement (3% to 20% change) | 9.0 | 9.4 | 9.7 |
| No Change (-3% to 3% change) | 1.3 | 0.0 | 3.2 |
| Deterioration (less than -3% change) | 5.1 | 6.3 | 5.4 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (>15% change) | 78.2 | 74.2 | 68.9 |
| Improvement (3% to 15% change) | 7.7 | 16.1 | 11.1 |
| No Change (-3% to 3% change) | 2.6 | 3.2 | 2.2 |
| Deterioration (less than -3% change) | 11.5 | 6.5 | 17.8 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (>15% change) | 52.6 | 50.0 | 54.4 |
| Improvement (3% to 15% change) | 19.2 | 22.6 | 21.1 |
| No Change (-3% to 3% change) | 9.0 | 3.2 | 5.6 |
| Deterioration (less than -3% change) | 19.2 | 24.2 | 18.9 |
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.
| Measure | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| VAS Satisfaction | 86.16 ± 23.750 | 82.09 ± 29.331 | 86.51 ± 23.531 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (more than -20mm change) | 76.9 | 72.6 | 78.5 |
| Improvement (-3mm to -20mm change) | 10.3 | 14.5 | 17.2 |
| No Change (-3mm to 3mm change) | 5.1 | 4.8 | 2.2 |
| Deterioration (more than 3mm) | 7.7 | 8.1 | 2.2 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (more than -20mm change) | 78.2 | 74.2 | 73.1 |
| Improvement (-3mm to -20mm change) | 10.3 | 11.3 | 12.9 |
| No Change (-3mm to 3mm change) | 9.0 | 3.2 | 3.2 |
| Deterioration (more than 3mm) | 2.6 | 11.3 | 10.8 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (more than -20mm change) | 66.7 | 74.2 | 68.8 |
| Improvement (-3mm to -20mm change) | 16.7 | 9.7 | 15.1 |
| No Change (-3mm to 3mm change) | 7.7 | 4.8 | 6.5 |
| Deterioration (more than 3mm) | 9.0 | 11.3 | 9.7 |
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.
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Significant Improvement (more than -20mm change) | 61.5 | 75.4 | 66.7 |
| Improvement (-3mm to -20mm change) | 21.8 | 8.2 | 15.1 |
| No Change (-3mm to 3mm change) | 10.3 | 8.2 | 7.5 |
| Deterioration (more than 3mm) | 6.4 | 8.2 | 10.8 |
% of subjects who would opt to have the surgery again if given the choice at 84 months
| % of Subjects | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Yes | 92.3 | 81.3 | 91.3 |
| Maybe | 6.4 | 14.1 | 7.6 |
| No | 1.3 | 4.7 | 1.1 |
Collected over 84 Months (i.e. 7 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ProDisc-C | — | 45/103 (43.7%) | 98/103 (95.1%) |
| Control | — | 53/106 (50%) | 100/106 (94.3%) |
| ProDisc-C Continued Access | — | 58/136 (42.6%) | 121/136 (89%) |
| Event | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Surgery - OtherSurgical and medical procedures | 21/103 | 27/106 | 18/136 |
| Surgery - Index LevelSurgical and medical procedures | 2/103 | 10/106 | 1/136 |
| Pain - Back and Lower ExtremitiesNervous system disorders | 6/103 | 2/106 | 4/136 |
| Pain - ShoulderNervous system disorders | 5/103 | 4/106 | 7/136 |
| GastrointestinalGastrointestinal disorders | 2/103 | 5/106 | 2/136 |
| Pain - Neck and Upper ExtremitiesNervous system disorders | 2/103 | 5/106 | 2/136 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/103 | 0/106 | 1/136 |
| Pain - BackNervous system disorders | 4/103 | 3/106 | 5/136 |
| GenitourinaryRenal and urinary disorders | 1/103 | 1/106 | 4/136 |
| DeathGeneral disorders | 3/103 | 3/106 | 4/136 |
| Event | ProDisc-C | Control | ProDisc-C Continued Access |
|---|---|---|---|
| Pain - NeckNervous system disorders | 35/103 | 41/106 | 59/136 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 34/103 | 22/106 | 39/136 |
| Surgery - OtherSurgical and medical procedures | 23/103 | 29/106 | 24/136 |
| HeadachesNervous system disorders | 27/103 | 21/106 | 31/136 |
| Pain - BackNervous system disorders | 26/103 | 22/106 | 32/136 |
| Pain - Upper ExtremitiesNervous system disorders | 20/103 | 15/106 | 34/136 |
| Pain - ShoulderNervous system disorders | 20/103 | 22/106 | 33/136 |
| NeurologicalPsychiatric disorders | 19/103 | 15/106 | 29/136 |
| Pain - Neck and Upper ExtremitiesNervous system disorders | 7/103 | 22/106 | 20/136 |
| GastrointestinalGastrointestinal disorders | 19/103 | 19/106 | 14/136 |
Number of subjects enrolled and treated
| Age, Continuous(Years) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| Mean | 42.1 ± 8.42 | 43.5 ± 7.15 | 43.4 ± 7.95 | 43.1 ± 7.86 |
| Sex: Female, Male(Participants) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| Female | 57 | 57 | 78 | 192 |
| Male | 46 | 49 | 58 | 153 |
| Race (NIH/OMB)(Participants) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 5 | 0 | 5 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 0 | 5 |
| White | 88 | 97 | 125 | 310 |
| More than one race | 3 | 5 | 2 | 10 |
| Unknown or Not Reported | 3 | 3 | 4 | 10 |
| Region of Enrollment(Participants) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| United States | 103 | 106 | 136 | 345 |
| Smoking Status(Subjects) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| Never | 51 | 49 | 79 | 179 |
| Former | 18 | 20 | 30 | 68 |
| Current | 34 | 37 | 27 | 98 |
| BMI(kg/m^2) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| Mean | 26.4 ± 5.32 | 27.3 ± 5.54 | 26.6 ± 5.07 | 26.8 ± 5.29 |
| Duration of Neck/Arm Pain(Subjects) | ProDisc-C | Control | ProDisc-C Continued Access | Total |
|---|---|---|---|---|
| < 6 weeks | 3 | 3 | 1 | 7 |
| 6 weeks to 1 year | 44 | 44 | 49 | 137 |
| > 1 year | 56 | 59 | 86 | 201 |
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Synthes USA HQ, Inc.