Slotted Hole Versus Fixed Hole C-Tek

NCT00585923 | Terminated Results

• 1 other identifier: CS-014
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Disc; Radiculopathy; Spondylolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 With Activity

  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.

  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)

  Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up)

Study Arms (2)

Usage of Fixed hole C-Tek™ Plate

ACTIVE COMPARATOR

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

Usage of Slotted hole C-Tek™ Plate

ACTIVE COMPARATOR

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

Device: Slotted hole C-Tek™ Plate

Interventions

Fixed hole C-Tek™ Plate DEVICE

Fixed hole C-Tek™ Plate

Usage of Fixed hole C-Tek™ Plate

Slotted hole C-Tek™ Plate DEVICE

Slotted hole C-Tek™ Plate

Usage of Slotted hole C-Tek™ Plate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy; Spondylolysis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spondylosis

Limitations and 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

Results Point of Contact

• Title: Jacquelyn Hughes
• Organization: Biomet

jacquelyn.hughes@biomet.com

973-299-9300

Study Officials

• Joel Batts

  Biomet Spine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 4, 2008
• Study Start: April 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 5, 2019
• Results First Posted: March 26, 2010

Record last verified: 2019-02

Locations

US (1)