Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAesculap AG
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient's clear unability or unwillingness to participate in follow-up examinations
Trial population
All patients who are treated with the Ennovate® Complex system system in accordance with the indications given in the instructions for use: Hyper- / hypokyphosis, Hyper- / hypolordosis, Scoliosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
posterior stabilization for the cervical spine
DeviceThe 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Ennovate® Complex1 intervention
Trial outcomes
Primary outcomes
1
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".
Time frame
preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperativelySecondary outcomes
1
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.
Time frame
preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively2
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.
Time frame
preoperatively, at 3-4 months postoperatively and at approximately 12 and 24 months postoperatively3
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.
Time frame
at final follow-up approximately 24 months after surgery4
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.
Time frame
throughout the follow-up up to 24 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Aesculap AG
Lead sponsor
Raylytic GmbH
Collaborator
Source ClinicalTrials.gov