Clinical trial NCT00443547: Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: Prospective
Degenerative Disc Disease
Cervical
Translational Plate
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeon's personal patient contacts

Brief 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.

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.

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

Primary outcomes:
measure: Radiographic Fusion
timeFrame: 24 Months
measure: Radiographic Fusion
timeFrame: 12 Months
Secondary outcomes:
measure: 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
timeFrame: 24 Months
Other outcomes:
Locations:
city: Carmichael
country: United States
facility: Roderick Sanden, MD
state: California
city: La Jolla
country: United States
facility: Yu-Po Lee, MD
state: California
city: Marysville
country: United States
facility: Ardavan Aslie, MD
state: California
city: Roseville
country: United States
facility: Barry Chehrazi, MD
state: California
city: Mount Vernon
country: United States
facility: Don Kovalsky, MD
state: Illinois
city: Fort Wayne
country: United States
facility: Mark Crawford, MD
state: Indiana
city: Clinton
country: United States
facility: Faheem Sandhu, MD
state: Maryland
city: Glen Burnie
country: United States
facility: Chris Urban, MD
state: Maryland
city: Flowood
country: United States
facility: John Moriarity, MD
state: Mississippi
city: Kettering
country: United States
facility: Jamal Taha, MD
state: Ohio
city: Charleston
country: United States
facility: Abhay Varma, MD
state: South Carolina
city: Tacoma
country: United States
facility: Daniel Nehls, MD
state: Washington
city: Milwaukee
country: United States
facility: Dennis Maiman, MD
state: Wisconsin
Study officials:
name: Donald Kovalsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: