Slotted Hole Versus Fixed Hole C-Tek

A Multi-Center Clinical Investigation of Slotted Hole Versus Fixed Hole C-Tek™ Anterior Cervical Plates

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.

Study Overview

• Status: Terminated
• Conditions: Radiculopathy; Herniated Disc; Spondylolysis
• Intervention / Treatment: Device: Fixed hole C-Tek™ Plate; Device: Slotted hole C-Tek™ Plate

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Joel Batts, Biomet Spine

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 4, 2008

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Spondylosis; Intervertebral Disc Displacement; Radiculopathy; Spondylolysis
• Other Study ID Numbers: CS-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED