Slotted Hole Versus Fixed Hole C-Tek

Zimmer Biomet115 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

115

Conditions

Herniated Disc Radiculopathy Spondylolysis

Interventions

Fixed hole C-Tek™ PlateDEVICE

Fixed hole C-Tek™ Plate

Slotted hole C-Tek™ PlateDEVICE

Slotted hole C-Tek™ Plate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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