Herniated Disc, Radiculopathy, Spondylolysis
Conditions
Brief summary
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
Detailed description
This study's purpose is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design
Interventions
DEVICEFixed hole C-Tek™ Plate
Fixed hole C-Tek™ Plate
DEVICESlotted hole C-Tek™ Plate
Slotted hole C-Tek™ Plate
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus. 2. Symptomatic radiculopathy appropriate to compressed nerve root. 3. Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy. 4. Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy. 5. Adult male or female, 18 to 75 years of age. 6. The subject or his/her legal guardian is willing to consent to participate in this study. 7. The subject will be available for follow-up for a minimum of 24 months.
Exclusion criteria
1. Traumatic cervical injury. 2. Posterior augmentation or revision fusion. 3. Cervical fusion involving C1 and C2 vertebrae. 4. Cervical fusion involving more than three levels. 5. Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate. 6. Systemic conditions: Spondylitis, Paget's disease, Rheumatoid arthritis, Infection within two weeks before surgery, Cancer, Renal disease or insufficiency with creatinine level above 2, Chronic use of steroids or other conditions that may affect bone metabolism 7. Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months. 8. Mental or physical conditions that may preclude compliance with physician instruction or the study protocol. 9. Subjects who require non-steroidal medications chronically for other conditions. 10. Subject declines to cooperate with the follow-up schedule. 11. Subject or legal guardian refuses or is unable to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion Success | Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views. Fusion Grading fused probably fused pseudarthrosis This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest | Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100. |
| Pain With Activity | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score. |
| Neurological Status Change in Neurological Status Since Surgery. | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome |
| Level of Function (Neck Disability Index) | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) | Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit. |
Countries
United States
Participant flow
Recruitment details
Recruitment was done through the population of Dr. Nunley's practice. Once Dr. Nunley decided that the patient was a candidate for cervical fusion, he discussed the study with the patient. After subject signed the informed consent subject was randomized to the Slotted Hole or the Fixed Hole C Tek™ Anterior Cervical Plate.
Pre-assignment details
Patients were included in this study if the answer to all of the inclusion criteria was yes and the answer to all of the exclusion questions was no.
Participants by arm
| Arm | Count |
|---|---|
| Fixed Hole C-Tek Plate Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | 56 |
| Slotted Hole C-Tek Plate Slotted Hole C-Tek Plate for ACDF | 59 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician decided not to continue | 31 | 33 |
Baseline characteristics
| Characteristic | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | Total |
|---|---|---|---|
| Age, Continuous | 49.46 years STANDARD_DEVIATION 10.26 | 50.03 years STANDARD_DEVIATION 10.04 | 49.76 years STANDARD_DEVIATION 10.1 |
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Customized Between 18 and 65 years | 46 Participants | 50 Participants | 96 Participants |
| Age, Customized Unknown | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Female | 32 Participants | 34 Participants | 66 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 56 | 0 / 59 |
| serious Total, serious adverse events | 2 / 56 | 0 / 59 |
Outcome results
Primary
Fusion Success
The fusion criteria will include radiographic evidence of no motion at the affected levels on flexion/extension and evidence of bony bridging and no lucent lines on AP/lateral views. Fusion Grading fused probably fused pseudarthrosis This determination was made by Dr. Nunley and there was never any more specific details given on how the determination was made between fused and probably fused.
Time frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Population: Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fixed Hole C-Tek Plate | Fusion Success | Solid Fused | 27 participants |
| Fixed Hole C-Tek Plate | Fusion Success | Probably Fused | 15 participants |
| Fixed Hole C-Tek Plate | Fusion Success | Pseudarthrosis (Failed Fusion) | 5 participants |
| Fixed Hole C-Tek Plate | Fusion Success | No Fusion Result | 9 participants |
| Slotted Hole C-Tek Plate | Fusion Success | No Fusion Result | 8 participants |
| Slotted Hole C-Tek Plate | Fusion Success | Solid Fused | 29 participants |
| Slotted Hole C-Tek Plate | Fusion Success | Pseudarthrosis (Failed Fusion) | 0 participants |
| Slotted Hole C-Tek Plate | Fusion Success | Probably Fused | 22 participants |
Secondary
Level of Function (Neck Disability Index)
Number of patients who have an improved, maintained or decreased level of function based on the results of their NDI (Neck Disabillity Index) from surgery to last follow-up visit. The NDI scale ranges from 0-100. If a subject has a score of 0, it means that they have no limitations and no pain. This is calculated by subtracting the NDI at the last follow-up from the NDI at the baseline visit.
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fixed Hole C-Tek Plate | Level of Function (Neck Disability Index) | Improved | 39 Participants |
| Fixed Hole C-Tek Plate | Level of Function (Neck Disability Index) | Decreased | 8 Participants |
| Fixed Hole C-Tek Plate | Level of Function (Neck Disability Index) | Maintained | 1 Participants |
| Fixed Hole C-Tek Plate | Level of Function (Neck Disability Index) | Not Measured at last visit | 8 Participants |
| Slotted Hole C-Tek Plate | Level of Function (Neck Disability Index) | Maintained | 2 Participants |
| Slotted Hole C-Tek Plate | Level of Function (Neck Disability Index) | Improved | 43 Participants |
| Slotted Hole C-Tek Plate | Level of Function (Neck Disability Index) | Not Measured at last visit | 7 Participants |
| Slotted Hole C-Tek Plate | Level of Function (Neck Disability Index) | Decreased | 7 Participants |
Secondary
Neurological Status Change in Neurological Status Since Surgery.
Patients were categorized as maintained, improved or decreased Neurological Status. This was assessed pre-operatively and at each follow-up visit but reported on last follow-up. Motor Function was measured at each cervical level Reflex Function (0: Not elicitable; 1: Elicited with reinforcement; 2: Normal; 3:Brisk; 4:Clonus, unsustained; 5: Clonus, sustained) was measured for Bicep, Brachioradialis, and Triceps Sensory Function (0: Sensation is absent; 1: Sensating is diminished; 2: Sensation is normal; 3: Sensation is present, but pathological, was measured at each cervical dermatome
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fixed Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Maintained | 17 Participants |
| Fixed Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Decreased | 1 Participants |
| Fixed Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Not Measured at last visit | 17 Participants |
| Fixed Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Improved | 21 Participants |
| Slotted Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Improved | 27 Participants |
| Slotted Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Maintained | 16 Participants |
| Slotted Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Not Measured at last visit | 13 Participants |
| Slotted Hole C-Tek Plate | Neurological Status Change in Neurological Status Since Surgery. | Decreased | 3 Participants |
Secondary
Pain at Rest
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain at Rest Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Best Case is 0 and worst case is 100.
Time frame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fixed Hole C-Tek Plate | Pain at Rest | Worsened | 4 Participants |
| Fixed Hole C-Tek Plate | Pain at Rest | Improved | 49 Participants |
| Fixed Hole C-Tek Plate | Pain at Rest | No Pain Recorded at Last Visit | 2 Participants |
| Fixed Hole C-Tek Plate | Pain at Rest | Maintained | 1 Participants |
| Slotted Hole C-Tek Plate | Pain at Rest | No Pain Recorded at Last Visit | 12 Participants |
| Slotted Hole C-Tek Plate | Pain at Rest | Improved | 45 Participants |
| Slotted Hole C-Tek Plate | Pain at Rest | Worsened | 0 Participants |
| Slotted Hole C-Tek Plate | Pain at Rest | Maintained | 2 Participants |
Secondary
Pain With Activity
Pain is calculated by patient making an X on a visual analog scale (VAS) line at each visit. Mark on x is measured via a mm ruler. Number of Participants with the Level of Pain with Activity Improved, Maintained or Worsened from Baseline to last follow-up visit. This is calculated by subtracting the pain at the last follow-up from the pain at the baseline visit. Scores range from 0 to 100 with 0 being the best score.
Time frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fixed Hole C-Tek Plate | Pain With Activity | Improved | 42 Participants |
| Fixed Hole C-Tek Plate | Pain With Activity | Maintained | 1 Participants |
| Fixed Hole C-Tek Plate | Pain With Activity | Worsened | 6 Participants |
| Fixed Hole C-Tek Plate | Pain With Activity | No pain recorded at last visit | 7 Participants |
| Slotted Hole C-Tek Plate | Pain With Activity | No pain recorded at last visit | 8 Participants |
| Slotted Hole C-Tek Plate | Pain With Activity | Improved | 46 Participants |
| Slotted Hole C-Tek Plate | Pain With Activity | Worsened | 4 Participants |
| Slotted Hole C-Tek Plate | Pain With Activity | Maintained | 1 Participants |