N/A N=231

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

Degenerative Disc Disease

Bottom Line

View on ClinicalTrials.gov: NCT00443547 ↗

Enrolled (actual)

231

Serious AEs

1.7%

Results posted

Jul 2019

Primary outcome: Primary: Radiographic Fusion — 66; 46; 37; 75 percentage of subjects

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Vectra-T (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Synthes USA HQ, Inc.
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Radiographic Fusion	48; 25; 27; 20	—
PRIMARY Radiographic Fusion	48; 25; 27; 20	—
SECONDARY 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	27; 29; 24; 17	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00443547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.