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Slotted Hole Versus Fixed Hole C-Tek

Primary Purpose

Herniated Disc, Radiculopathy, Spondylolysis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fixed hole C-Tek™ Plate
Slotted hole C-Tek™ Plate
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herniated Disc

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spine Institute of Louisiana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usage of Fixed hole C-Tek™ Plate

Usage of Slotted hole C-Tek™ Plate

Arm Description

Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability

Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
December 21, 2007
Last Updated
February 11, 2019
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00585923
Brief Title
Slotted Hole Versus Fixed Hole C-Tek
Official Title
A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of follow-up information
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disc, Radiculopathy, Spondylolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usage of Fixed hole C-Tek™ Plate
Arm Type
Active Comparator
Arm Description
Fixed Hole Plate - The fixed hole plate means that the screws do not move, restricting motion and providing additional stability
Arm Title
Usage of Slotted hole C-Tek™ Plate
Arm Type
Active Comparator
Arm Description
Slotted Hole Plate - Bone screw translates while plate is stationary, which ultimately promotes grafts settling through load sharing.
Intervention Type
Device
Intervention Name(s)
Fixed hole C-Tek™ Plate
Intervention Description
Fixed hole C-Tek™ Plate
Intervention Type
Device
Intervention Name(s)
Slotted hole C-Tek™ Plate
Intervention Description
Slotted hole C-Tek™ Plate
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Batts
Organizational Affiliation
Biomet Spine
Official's Role
Study Director
Facility Information:
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Slotted Hole Versus Fixed Hole C-Tek

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