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OpenTrials
Completed

NCT Number: NCT03550846

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

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.

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Key information

Conditions

Spinal Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APEX Spine Wirbelsäulenpraxis, München, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: preoperative, 12 months postoperative

    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.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: TENNIS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 8, 2018
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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