Clinical trial NCT00585923: 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
Overall status: TERMINATED
Phase: NA
Conditions: Herniated Disc
Radiculopathy
Spondylolysis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Fusion Success
timeFrame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Secondary outcomes:
measure: Pain at Rest
timeFrame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
measure: Pain With Activity
timeFrame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
measure: Neurological Status Change in Neurological Status Since Surgery.
timeFrame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
measure: Level of Function (Neck Disability Index)
timeFrame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
Study officials:
affiliation: Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References: