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Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Neck Specific Disability measured by Neck Disability Index (NDI) | The 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. | preoperative, 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| JOA score | The Japanese Orthopaedic Association (JOA) score is a widely used tool to assess the severity of clinical symptoms in patients with cervical compressive myelopathy. Motor function (Upper extremity/Lower extremity); Sensory (Upper extremity/lower extremity/trunk); Bladder function. The Score reaches a maximum of 17 and a Minimum of 0 points. | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
• Patient is not willing or able to participate at the follow-up examination
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Nikolaus Kroppenstedt, Dr. med. | Abteilung für Wirbelsäulenchirurgie Sana Kliniken Sommerfeld | Principal Investigator |
| Francis Kilian, Dr. med. | Katholisches Klinikum Koblenz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholisches Klinikum Koblenz | Koblenz | 56073 | Germany | |||
| Sana Kliniken Sommerfeld |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| Pain (VAS) | The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image. | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively |
| development of EQ-5D-5L | 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. | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively |
| development of radiological outcome | if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration) | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively |
| Rate of AE/SAEs | Rate of AE/SAEs during the postoperative course | preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively |
| Patient Satisfaction with Treatment Outcome | Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say) | at one follow-up- assessment after a minimum of one year postoperatively |
| Kremmen |
| 16766 |
| Germany |
| D009140 |
| Musculoskeletal Diseases |