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

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DePuy Synthes

Status

Completed

Conditions

Degenerative Disc Disease

Treatments

Device: Vectra-T

Study type

Observational

Funder types

Industry

Identifiers

NCT00443547
VECTR 1492

Details and patient eligibility

About

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.

Full 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.

Enrollment

231 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

231 participants in 4 patient groups

1-level
Description:
Patients needing a single level cervical fusion with Vectra-T
Treatment:
Device: Vectra-T
2-level
Description:
Patients needing cervical fusion at two consecutive levels with Vectra-T
Treatment:
Device: Vectra-T
3-level
Description:
Patients needing cervical fusion at three consecutive levels with Vectra-T
Treatment:
Device: Vectra-T
4-level
Description:
Patients needing cervical fusion at four consecutive levels with Vectra-T
Treatment:
Device: Vectra-T

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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