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

Aesculap

Status

Enrolling

Conditions

Neuromuscular Scoliosis

Hyperlordosis

Idiopathic Scoliosis

Congenital Scoliosis

Hyperkyphosis

Treatments

Device: posterior stabilization for the cervical spine

Study type

Observational

Funder types

Industry

Identifiers

NCT05281757

AAG-O-H-2022

Details and patient eligibility

About

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)

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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