Spinal FusionTENNISNCT03550846
Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)
An observational study of Spinal Fusion, run by Aesculap AG at 7 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion
- How many people
- 188 participants
- Where
- 7 sitesGermany
- Study dates
- 12 Apr 2018to 18 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Consent in the documentation of clinical and radiological results
Who cannot join
- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Carolin Meyer
Cologne, 50924
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60528
Klinik und Poliklinik für Neurochirurgie
Göttingen, 37075
Katholisches Klinikum Koblenz
Koblenz, 56073
APEX Spine Wirbelsäulenpraxis
München, Bavaria, 80637
medius Klinik
Nürtingen, 72622
Praxis für Neurochirurgie am Klinikum
Tuttlingen, 78532
About this study
Official title: Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
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.
Read the detailed 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.
- Conditions
- Spinal Fusion
- Keywords
- Spinal Fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperative, 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start12 Apr 2018
- Primary completion27 May 2021
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolin Meyer, Dr., Principal investigator, Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550846
- Sponsor's protocol ID
- AAG-O-H-1639
- Acronym
- TENNIS
- Status last verified
- Jan 2023
- First submitted
- 25 May 2018
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
- ClinicalTrials.gov ID
- NCT03550846
- Acronym / sponsor ID
- TENNIS / AAG-O-H-1639
- Conditions
- Spinal Fusion
- Keywords
- Spinal Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (1 listed)
- Consent in the documentation of clinical and radiological results
Key exclusion criteria (1 listed)
- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Meyer, Dr. principal investigator
Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion, run by Aesculap AG at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months (time frame: preoperative, 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.