Slotted Hole Versus Fixed Hole C-Tek
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Usage of Fixed hole C-Tek™ Plate Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability |
Device: Fixed hole C-Tek™ Plate
Fixed hole C-Tek™ Plate
|
Active Comparator: Usage of Slotted hole C-Tek™ Plate Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing. |
Device: Slotted hole C-Tek™ Plate
Slotted hole C-Tek™ Plate
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
-
Symptomatic radiculopathy appropriate to compressed nerve root.
-
Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
-
Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
-
Adult male or female, 18 to 75 years of age.
-
The subject or his/her legal guardian is willing to consent to participate in this study.
-
The subject will be available for follow-up for a minimum of 24 months.
Exclusion Criteria:
-
Traumatic cervical injury.
-
Posterior augmentation or revision fusion.
-
Cervical fusion involving C1 and C2 vertebrae.
-
Cervical fusion involving more than three levels.
-
Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.
-
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
-
Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months.
-
Mental or physical conditions that may preclude compliance with physician instruction or the study protocol.
-
Subjects who require non-steroidal medications chronically for other conditions.
-
Subject declines to cooperate with the follow-up schedule.
-
Subject or legal guardian refuses or is unable to sign the informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Spine Institute of Louisiana | Shreveport | Louisiana | United States | 71101 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Study Director: Joel Batts, Biomet Spine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS-014
Study Results
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 Detail | 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. |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Period Title: Overall Study | ||
STARTED | 56 | 59 |
COMPLETED | 25 | 26 |
NOT COMPLETED | 31 | 33 |
Baseline Characteristics
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | Total |
---|---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF | Total of all reporting groups |
Overall Participants | 56 | 59 | 115 |
Age, Customized (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
46
82.1%
|
50
84.7%
|
96
83.5%
|
>=65 years |
5
8.9%
|
7
11.9%
|
12
10.4%
|
Unknown |
5
8.9%
|
2
3.4%
|
7
6.1%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
49.46
(10.26)
|
50.03
(10.04)
|
49.76
(10.10)
|
Sex: Female, Male (Count of Participants) | |||
Female |
32
57.1%
|
34
57.6%
|
66
57.4%
|
Male |
24
42.9%
|
25
42.4%
|
49
42.6%
|
Outcome Measures
Title | Fusion Success |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
Fusion Status is shown for the last office visit which the patient attended before the doctor withdrew from the study |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Measure Participants | 56 | 59 |
Solid Fused |
27
48.2%
|
29
49.2%
|
Probably Fused |
15
26.8%
|
22
37.3%
|
Pseudarthrosis (Failed Fusion) |
5
8.9%
|
0
0%
|
No Fusion Result |
9
16.1%
|
8
13.6%
|
Title | Pain at Rest |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Measure Participants | 56 | 59 |
Improved |
49
87.5%
|
45
76.3%
|
Maintained |
1
1.8%
|
2
3.4%
|
Worsened |
4
7.1%
|
0
0%
|
No Pain Recorded at Last Visit |
2
3.6%
|
12
20.3%
|
Title | Pain With Activity |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Measure Participants | 56 | 59 |
Improved |
42
75%
|
46
78%
|
Maintained |
1
1.8%
|
1
1.7%
|
Worsened |
6
10.7%
|
4
6.8%
|
No pain recorded at last visit |
7
12.5%
|
8
13.6%
|
Title | Neurological Status Change in Neurological Status Since Surgery. |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Measure Participants | 56 | 59 |
Improved |
21
37.5%
|
27
45.8%
|
Maintained |
17
30.4%
|
16
27.1%
|
Decreased |
1
1.8%
|
3
5.1%
|
Not Measured at last visit |
17
30.4%
|
13
22%
|
Title | Level of Function (Neck Disability Index) |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate |
---|---|---|
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF |
Measure Participants | 56 | 59 |
Improved |
39
69.6%
|
43
72.9%
|
Maintained |
1
1.8%
|
2
3.4%
|
Decreased |
8
14.3%
|
7
11.9%
|
Not Measured at last visit |
8
14.3%
|
7
11.9%
|
Adverse Events
Time Frame | Adverse event data was collected through the 24 mnth visit | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | ||
Arm/Group Description | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) | Slotted Hole C-Tek Plate for ACDF | ||
All Cause Mortality |
||||
Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/56 (3.6%) | 0/59 (0%) | ||
Surgical and medical procedures | ||||
Instrument Failure - Screw Breakage | 1/56 (1.8%) | 1 | 0/59 (0%) | 0 |
Instrument Failure - Screw Back-out | 1/56 (1.8%) | 1 | 0/59 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/56 (1.8%) | 0/59 (0%) | ||
Infections and infestations | ||||
Mild Wound Drainage | 1/56 (1.8%) | 1 | 0/59 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jacquelyn Hughes |
---|---|
Organization | Biomet |
Phone | 973-299-9300 ext 3075 |
jacquelyn.hughes@biomet.com |
- CS-014