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

June 5, 2019 updated by: Synthes USA HQ, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic Fusion
Time Frame: 24 Months
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
24 Months
Radiographic Fusion
Time Frame: 12 Months
Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 24 Months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synthes USA HQ, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donald Kovalsky, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VECTR 1492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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