Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)

Aesculap AG188 enrolled

Overview

This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.

The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency. 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 trauma and degenerative disorders.

Study Type

OBSERVATIONAL

Enrollment

188

Conditions

Spinal Fusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Consent in the documentation of clinical and radiological results Exclusion Criteria: \- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.

Locations (7)

APEX Spine Wirbelsäulenpraxis

München, Bavaria, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Carolin Meyer

Cologne, Germany

Klinik und Poliklinik für Neurochirurgie

Göttingen, Germany

Outcomes

Primary Outcomes

Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months

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: preoperative, 12 months postoperative

Data from ClinicalTrials.gov

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