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

Idiopathic Scoliosis Clinical Trial

— COSINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281757
• Other study ID #: AAG-O-H-2022
• Status: Recruiting
• Start date: February 18, 2022
• Est. completion date: October 2028

Study information

• Verified date: April 2024
• Source: Aesculap AG
• Contact: Sarah Mattes
• Phone: +497461950
• Email: sarah.mattes[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2028
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperkyphosis
• Idiopathic Scoliosis
• Kyphosis
• Neuromuscular Scoliosis
• Scoliosis

Intervention

Device:
• posterior stabilization for the cervical spine
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.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno
Malaysia	Hospital Universiti Kebangsaan Malaysia (HUKM)	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	Raylytic GmbH

Countries where clinical trial is conducted

Czechia,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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