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Completed

NCT Number: NCT00443547

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roderick Sanden, MD, Carmichael, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vectra-T

Device

Patient will receive the Vectra-T plate (Sized 1 to 4 levels)

Other names: Vectra-T Translational Plating System

Primary outcomes

  1. Radiographic Fusion

    Time frame: 24 Months

    Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

  2. Radiographic Fusion

    Time frame: 12 Months

    Percentage of subjects who were successfully fused per an independent radiographic assessment at all index levels

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Synthes USA HQ, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2007
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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