Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)
TENNIS
Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
1 other identifier
observational
188
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2018
CompletedFirst Submitted
Initial submission to the registry
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2022
CompletedJanuary 17, 2023
January 1, 2023
3.1 years
May 25, 2018
January 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
adult patients
You may qualify if:
- \- Consent in the documentation of clinical and radiological results
You may not qualify if:
- \- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (7)
APEX Spine Wirbelsäulenpraxis
München, Bavaria, 80637, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60528, Germany
Carolin Meyer
Cologne, 50924, Germany
Klinik und Poliklinik für Neurochirurgie
Göttingen, 37075, Germany
Katholisches Klinikum Koblenz
Koblenz, 56073, Germany
medius Klinik
Nürtingen, 72622, Germany
Praxis für Neurochirurgie am Klinikum
Tuttlingen, 78532, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Carolin Meyer, Dr.
Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 8, 2018
Study Start
April 12, 2018
Primary Completion
May 27, 2021
Study Completion
November 18, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01