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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-18

Study Completion Date

2028-10-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Hyperkyphosis Hyperlordosis Congenital Scoliosis Neuromuscular Scoliosis Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ennovate® Complex

All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU)

posterior stabilization for the cervical spine

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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