Degenerative Instability, Post-discectomy Syndrome, Post-traumatic Instabilities, Spondylolisthesis
Conditions
Keywords
Cervical Vertebrae;, Spondylolisthesis;, Treatment Outcome;, Interbody Fusion
Brief summary
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is minimum 18 years old * Written informed consent for the documentation of clinical and radiological results * Patient's indication according to IFU * Patient is not pregnant
Exclusion criteria
• Patient is not willing or able to participate at the follow-up examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Neck Specific Disability measured by Neck Disability Index (NDI) | preoperative, 12 months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| development of radiological outcome | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively | if provided in the clinical standard; e.g. fusion, implant subsidence, implant migration) |
| JOA score | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively | 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. |
| development of EQ-5D-5L | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively | 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. |
| Rate of AE/SAEs | preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively | Rate of AE/SAEs during the postoperative course |
| Patient Satisfaction with Treatment Outcome | at one follow-up- assessment after a minimum of one year postoperatively | 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) |
| Pain (VAS) | preoperatively and at one follow-up- assessment after a minimum of one year postoperatively | 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. |
Countries
Germany
Outcome results
None listed