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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Scoliosis; Hyperlordosis; Neuromuscular Scoliosis; Hyperkyphosis; Congenital Scoliosis
• Intervention / Treatment: Device: posterior stabilization for the cervical spine

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Stefan Maenz; Phone Number: +497461950; Email: stefan.maenz@aesculap.de

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno
    • Contact: Martin Repko, MUDr.; Email: repko@med.muni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ennovate® Complex; 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; 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.

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: Raylytic GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: upper-thoracic spine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Kyphosis
• Other Study ID Numbers: AAG-O-H-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No