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

Spinal Fusion Clinical Trial

— TENNIS  

Official title:

Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550846
• Other study ID #: AAG-O-H-1639
• Status: Completed
• Start date: April 12, 2018
• Est. completion date: November 18, 2022

Study information

• Verified date: January 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: November 18, 2022
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Fusion

Locations

Country	Name	City	State
Germany	Universitätsklinikum Frankfurt	Frankfurt	Hessen
Germany	Klinik und Poliklinik für Neurochirurgie	Göttingen
Germany	Katholisches Klinikum Koblenz	Koblenz
Germany	Carolin Meyer	Köln
Germany	APEX Spine Wirbelsäulenpraxis	München	Bayern
Germany	medius Klinik	Nürtingen
Germany	Praxis für Neurochirurgie am Klinikum	Tuttlingen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	preoperative, 12 months postoperative