Slotted Hole Versus Fixed Hole C-Tek

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00585923
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 73
• Patients Per Site Per Month: 1.6

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
Herniated Disc; Radiculopathy; Spondylolysis	Device: Fixed hole C-Tek™ Plate; Device: Slotted hole C-Tek™ Plate	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

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

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

1. 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

1. 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.

2. 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.

3. 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

4. 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

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

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.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00585923
• Other Study ID Numbers: CS-014
• First Posted: Jan 4, 2008
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Intervertebral Disc Displacement; Spondylolysis; Radiculopathy

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

1. Primary Outcome

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%

2. Secondary Outcome

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%

3. Secondary Outcome

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%

4. Secondary Outcome

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%

5. Secondary Outcome

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
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

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

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.