CERISE: Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Study Details
Study Description
Brief Summary
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ennovate® Cervical Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use |
Device: 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.
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Outcome Measures
Primary Outcome Measures
- Change of Pain [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 Measures
- Change of Quality of life [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.
- Change of Neurological status [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.
- Change of Disability [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.
- Bone fusion [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.
- Cumulative number of side effects [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is minimum 18 years old
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Informed Consent in the documentation of clinical and radiological results
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Patient has indication according to Instructions for Use (IFU)
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Patient is not pregnant
Exclusion Criteria:
- Patient's clear unability or unwillingness to participate in follow-up examinations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Schön Klinik Hamburg Eilbek | Hamburg | Germany | 22081 |
Sponsors and Collaborators
- Aesculap AG
- Raylytic GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-2010