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Due to lack of follow-up information
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usage of Fixed hole C-Tek™ Plate | Active Comparator | Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability |
|
| Usage of Slotted hole C-Tek™ Plate | Active Comparator | Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed hole C-Tek™ Plate | Device | Fixed hole C-Tek™ Plate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Batts | Biomet Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Hole C-Tek Plate | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) |
| FG001 | Slotted Hole C-Tek Plate | Slotted Hole C-Tek Plate for ACDF |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed Hole C-Tek Plate | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) |
| BG001 | Slotted Hole C-Tek Plate | Slotted Hole C-Tek Plate for ACDF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | There were 5 patients in the fixed hole group and 2 patients in the slotted hole group who do not have calculated age due to missing information that we were unable to obtain from the clinical site |
| 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 | 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. | Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study | Posted | Number | participants | Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
|
Adverse event data was collected through the 24 mnth visit
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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 | Fixed Hole C-Tek Plate | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instrument Failure - Screw Breakage | Surgical and medical procedures | Systematic Assessment | Breakage of 2 screws |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Wound Drainage | Infections and infestations | Systematic Assessment | Patient experienced a mild wound drainage |
Early termination of this study because the doctor involved in the study decided that he did not want to participate in the study any more. The site also did not have very good follow-up on all of their patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacquelyn Hughes | Biomet | 973-299-9300 | 3075 | jacquelyn.hughes@biomet.com |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| D013169 | Spondylolysis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Slotted hole C-Tek™ Plate |
| Device |
Slotted hole C-Tek™ Plate |
|
| Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
| 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. | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
| 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 | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
| 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. | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Slotted Hole C-Tek Plate |
Slotted Hole C-Tek Plate for ACDF |
|
|
| 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. | Posted | Number | Participants | Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
|
|
|
| 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. | Posted | Number | Participants | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
|
|
|
| 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 | Posted | Number | Participants | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
|
|
|
| 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. | Posted | Number | Participants | Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) |
|
|
|
| 2 |
| 56 |
| 1 |
| 56 |
| EG001 | Slotted Hole C-Tek Plate | Slotted Hole C-Tek Plate for ACDF | 0 | 59 | 0 | 59 |
|
| Instrument Failure - Screw Back-out | Surgical and medical procedures | Systematic Assessment | Screw backed out of the plate |
|
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D055009 | Spondylosis |
| Worsened |
|
| No Pain Recorded at Last Visit |
|
| Worsened |
|
| No pain recorded at last visit |
|
| Decreased |
|
| Not Measured at last visit |
|
| Decreased |
|
| Not Measured at last visit |
|