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Slotted Hole Versus Fixed Hole C-Tek

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ClinicalTrials.gov Identifier: NCT00585923
Recruitment Status : Terminated (Due to lack of follow-up information)
First Posted : January 4, 2008
Results First Posted : March 26, 2010
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Herniated Disc
Radiculopathy
Spondylolysis
Interventions Device: Fixed hole C-Tek™ Plate
Device: Slotted hole C-Tek™ Plate
Enrollment 115
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.
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide 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
Reason Not Completed
Physician decided not to continue             31             33
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate Total
Hide 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 Number of Baseline Participants 56 59 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 59 participants 115 participants
<=18 years
0
   0.0%
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%
[1]
Measure Description: 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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 59 participants 115 participants
49.46  (10.26) 50.03  (10.04) 49.76  (10.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 59 participants 115 participants
Female
32
  57.1%
34
  57.6%
66
  57.4%
Male
24
  42.9%
25
  42.4%
49
  42.6%
1.Primary Outcome
Title Fusion Success
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate for ACDF
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Unit of Measure: participants
Solid Fused 27 29
Probably Fused 15 22
Pseudarthrosis (Failed Fusion) 5 0
No Fusion Result 9 8
2.Secondary Outcome
Title Pain at Rest
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide Arm/Group Description:
Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate for ACDF
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Unit of Measure: Participants
Improved 49 45
Maintained 1 2
Worsened 4 0
No Pain Recorded at Last Visit 2 12
3.Secondary Outcome
Title Pain With Activity
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide Arm/Group Description:
Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate for ACDF
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Unit of Measure: Participants
Improved 42 46
Maintained 1 1
Worsened 6 4
No pain recorded at last visit 7 8
4.Secondary Outcome
Title Neurological Status Change in Neurological Status Since Surgery.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide Arm/Group Description:
Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate for ACDF
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Unit of Measure: Participants
Improved 21 27
Maintained 17 16
Decreased 1 3
Not Measured at last visit 17 13
5.Secondary Outcome
Title Level of Function (Neck Disability Index)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide Arm/Group Description:
Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate for ACDF
Overall Number of Participants Analyzed 56 59
Measure Type: Number
Unit of Measure: Participants
Improved 39 43
Maintained 1 2
Decreased 8 7
Not Measured at last visit 8 7
Time Frame Adverse event data was collected through the 24 mnth visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/56 (3.57%)      0/59 (0.00%)    
Surgical and medical procedures     
Instrument Failure - Screw Breakage  [1]  1/56 (1.79%)  1 0/59 (0.00%)  0
Instrument Failure - Screw Back-out  [2]  1/56 (1.79%)  1 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Breakage of 2 screws
[2]
Screw backed out of the plate
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fixed Hole C-Tek Plate Slotted Hole C-Tek Plate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/56 (1.79%)      0/59 (0.00%)    
Infections and infestations     
Mild Wound Drainage  [1]  1/56 (1.79%)  1 0/59 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
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
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
Layout table for Results Point of Contact information
Name/Title: Jacquelyn Hughes
Organization: Biomet
Phone: 973-299-9300 ext 3075
EMail: jacquelyn.hughes@biomet.com
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00585923     History of Changes
Other Study ID Numbers: CS-014
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: November 11, 2009
Results First Posted: March 26, 2010
Last Update Posted: March 5, 2019