Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease

Prospective Multi-Center Clinical Study of Patients With Degenerative Disc Disease Treated With Anterior Cervical Decompression and Fusion Using the Vectra-T Translational Cervical Plate.

The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Vectra-T

Detailed Description

This is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (DDD) and treated using the Vectra-T Cervical Plate and the Advanced ACF or CorticoCancellous Allograft Spacer made by Synthes Spine Company (Paoli, PA). This is not an investigational study (IDE) and no investigational or experimental devices or procedures are included in this study.

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• United States
  • California
    • Carmichael, California, United States, 95608
      • Roderick Sanden, MD
    • La Jolla, California, United States, 92093-0706
      • Yu-Po Lee, MD
    • Marysville, California, United States, 95901
      • Ardavan Aslie, MD
    • Roseville, California, United States, 95661
      • Barry Chehrazi, MD
  • Illinois
    • Mount Vernon, Illinois, United States, 62864
      • Don Kovalsky, MD
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Mark Crawford, MD
  • Maryland
    • Clinton, Maryland, United States, 20735
      • Faheem Sandhu, MD
    • Glen Burnie, Maryland, United States, 21061
      • Chris Urban, MD
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • John Moriarity, MD
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Jamal Taha, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Abhay Varma, MD
  • Washington
    • Tacoma, Washington, United States, 98405
      • Daniel Nehls, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Dennis Maiman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgeon's personal patient contacts

Description

Inclusion Criteria:

• One to four levels (consecutive) cervical degenerative disc disease between C2 and C7, defined as at least one of the following:

  • disc herniation
  • axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis
  • functional deficit
  • neurological deficit which significantly limits patient's normal living
• One to four cervical levels to be plated
• Patient is skeletally mature and at least 18 years of age
• Patient signs consent form
• Patient is available for long term (24 month) follow-up
• Etiology must be confirmed by MRI or CT

Exclusion Criteria:

• Spondylolisthesis greater than grade 1 at either level(s) to be instrumented
• Indications for complete corpectomy of any involved levels
• Posterior instrumentation is necessary at same levels
• More than one previous failed anterior fusion attempt at the involved level(s)
• Has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on Flexion/Extension radiographs.
• Pregnant or interested in becoming pregnant during the study follow-up period
• Has a known sensitivity to device materials
• Mentally incompetent or prisoner
• Currently a participant in a study related to the treatment of cervical spinal disorders
• Pre-op instability>3mm on flexion/extension X-rays

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1-level; Patients needing a single level cervical fusion with Vectra-T	Device: Vectra-T; Patient will receive the Vectra-T plate (Sized 1 to 4 levels); Other Names: Vectra-T Translational Plating System
2-level; Patients needing cervical fusion at two consecutive levels with Vectra-T	Device: Vectra-T; Patient will receive the Vectra-T plate (Sized 1 to 4 levels); Other Names: Vectra-T Translational Plating System
3-level; Patients needing cervical fusion at three consecutive levels with Vectra-T	Device: Vectra-T; Patient will receive the Vectra-T plate (Sized 1 to 4 levels); Other Names: Vectra-T Translational Plating System
4-level; Patients needing cervical fusion at four consecutive levels with Vectra-T	Device: Vectra-T; Patient will receive the Vectra-T plate (Sized 1 to 4 levels); Other Names: Vectra-T Translational Plating System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Fusion	Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels	24 Months
Radiographic Fusion	Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index (NDI) is a Widely Used Instrument for Assessing Self-reported Disability in Patients With Neck Pain. Scoring is Reported on a 0-100 Point Scale, 0 Being the Best Possible Score and 100 Being the Worst Possible Score	Average NDI score at 24 months - score range is 0 to 100, with 0 being the best and 100 being the worst	24 Months

Collaborators and Investigators

• Sponsor: Synthes USA HQ, Inc.
• Investigators: Principal Investigator: Donald Kovalsky, M.D.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2006
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 2, 2007
• First Submitted That Met QC Criteria: March 5, 2007
• First Posted (Estimate): March 6, 2007

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Cervical; Degenerative Disc Disease; Prospective; Translational Plate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: VECTR 1492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO