ISRCTN42774128
Completed
未知
Prospective International multicentre Evaluation of Radiological and Clinical Effects of stand-alone polyetheretherketone (PEEK) intervertebral spacers for anterior cervical discectomy and fusion (ACDF): a prospective single-arm observational surgical implant trial
Deutsche Arthrose Hilfe e.V. (Germany)0 sites356 target enrollmentApril 22, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cervical degenerative disc disease
- Sponsor
- Deutsche Arthrose Hilfe e.V. (Germany)
- Enrollment
- 356
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2017 results in https://pubmed.ncbi.nlm.nih.gov/28465721/ (added 30/12/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age greater than or equal to 18 years, either sex
- •2\. Cervical degenerative disc disease at a single level, C3/C4 \- C7/Th1
- •3\. Clinical signs of myelopathy or radiculopathy
- •4\. Presence of neck/arm pain (cervicobrachialgia) and/or radicular deficits, which are refractory to conservative therapy
Exclusion Criteria
- •1\. Unable to provide informed consent to surgery
- •2\. Osteoporosis, fractures, or concomitant tumours of the cervical vertebrae
- •3\. Previous surgery in the affected level
- •4\. Fusion of either immediately adjacent level (due either to a previous operation or natural history)
- •5\. Kyphosis or instability/hypermobility in functional x\-rays (because this was taken as an indication for ventral plating)
- •6\. Systemic, spinal, or local infection (acute or chronic)
- •7\. Known allergies or intolerance to the implant material PEEK
Outcomes
Primary Outcomes
Not specified
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