Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex

Study Overview
=================
Brief Summary
-----------------
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not interventional, multicentric)

Detailed Description
-----------------
This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex 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 deformity disorders.

Official Title
-----------------
Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients

Conditions
-----------------
Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis, Idiopathic Scoliosis

Intervention / Treatment
-----------------
* Device: posterior stabilization for the cervical spine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18 Patient's indication according to IFU Patient is not pregnant Exclusion Criteria: Patient's clear unability or unwillingness to participate in follow-up examinations
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ennovate® Complex<br>All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU) | Device: posterior stabilization for the cervical spine<br>* The Ennovate® Complex Spinal System is a posterior stabilization for the Complex and upper-thoracic spine. The implants are used for the posterior multisegmental correction and stabilization over all sections of the spine.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain | ain will be assessed by the patient using the Visual Analogue Scale (VAS) which state 0 at one end representing no pain and 100 at the opposite end representing maximal / worst pain. | preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Quality of Life | In order to analyze the quality of life of the patients, the most current questionnaire of the Scoliosis Research Society (SRS), the SRS-30 is used. The SRS-30 demonstrates how spinal conditions impact quality of life and facilitate comparisons of the quality of life before and after surgical intervention. It is widely used in the evaluation of the treatment of idiopathic scoliosis patients. SRS-30 is a patient self administered questionnaire and has a minimum score of 30 and a maximum score of 150 including postsurgery questions. Each question is scored on 1-5 scale. Questions are sorted into different domains and total and mean scores for each domain are calculated. A total score for the entire questionnaire is also calculated. | preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively | 
| Change of Every day life | Clinical Results measured by Oswestry Disability Index (ODI). ODI contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0 (indicating the least amount of disability) to 5 5 (indicating most severe disability). The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively | 
| Bone Fusion | After Complex 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. | at final follow-up approximately 24 months after surgery | 
| Cumulative number of Side effects | 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. | throughout the follow-up up to 24 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper-thoracic spine