PMCF Study on the Safety and Performance of CESPACE 3D

Study Overview
=================
Brief Summary
-----------------
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)

Official Title
-----------------
Multicenter PMCF Study on the Safety and Performance of CESPACE 3D - A Prospective Study on Total Indications

Conditions
-----------------
Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Vertebrae;, Spondylolisthesis;, Treatment Outcome;, Interbody Fusion