N/A
Completed N=231
Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease
Source: ClinicalTrials.gov NCT00443547 ↗Enrolled (actual)
231
Serious AEs
1.7%
Results posted
Jul 2019
Primary outcomePrimary: Radiographic Fusion — 66; 46; 37; 75 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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
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. Informational only — not medical advice.