1. Change of Pain (Time Frame - preoperatively, at 3 months postoperatively and at 12 months postoperatively): Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".
Secondary outcome:
1. Change of Quality of life (Time Frame - preoperatively, at 3 months postoperatively and at 12 months postoperatively): In order to analyze the quality of life of the patients, the 5-dimension 5-level score of EuroQol Group (EQ-5D-5L) is used. The score is self-completed by the patient. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
2. Change of Neurological status (Time Frame - preoperatively, at 3 months postoperatively and at 12 months postoperatively): The Japanese Orthopaedic Association (JOA) myelopathy score is a disease-specific and physician oriented system that mainly assesses the neurological status of the patient and enables surgeons to compare the changes in the neurological status of the patient before and after certain treatments. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health (physical and mental health), which can be affected by cervical myelopathy.
3. Change of Disability (Time Frame - preoperatively, at 3 months postoperatively and at 12 months postoperatively): The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
4. Bone fusion (Time Frame - at final follow-up 12 months postoperatively): After cervical stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.
5. Cumulative number of side effects (Time Frame - throughout the follow-up up to 12 months postoperatively): Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.
posterior stabilization for the cervical spine: The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical"
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