Spine FractureCERISENCT05296889
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
An observational study of Spine Fracture and Degenerative Disc Disease, run by Aesculap AG at 4 sites in Germany.
Trial summary
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fracture, Degenerative Disc Disease, Spinal Instability
- What is being tested?
- posterior stabilization for the cervical spine
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesGermany
- Study dates
- 21 Jul 2021to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use: fractures, degenerative instability, post-trauma instability, tumors, degenerative cervical myelopathy
Who may be able to join
- Patient is minimum 18 years old
- Informed Consent in the documentation of clinical and radiological results
- Patient has indication according to Instructions for Use (IFU)
- Patient is not pregnant
Who cannot join
- Patient's clear unability or unwillingness to participate in follow-up examinations
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 3 recruiting
- Not yet recruiting
Städtisches Klinikum Dresden
Dresden, Saxony, 01076
Philip Gierer, Prof. Dr.
Gierer, Prof. Dr.
- Recruiting
Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
Halle, Saxony-Anhalt, 06112
Klaus Röhl, Dr.
Klaus Röhl, Dr.
- Active, not recruiting
Schön Klinik Hamburg Eilbek
Hamburg, Free and Hanseatic City of Hamburg, 22081
- Not yet recruiting
Krankenhaus Ludmillenstift Meppen
Meppen, Lower Saxony, 49716
Felix Kiepe, Dr.
Felix Kiepe, Dr.
About this study
Official title: Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
Read the detailed description
This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. 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
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor, Degenerative Myelopathy
- Being tested
- posterior stabilization for the cervical spine
- Keywords
- Cervical Spine
- Medical subject headings
- Spinal Fractures, Intervertebral Disc Degeneration, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior stabilization for the cervical spineDevice
The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.
| Study group | Role | What they receive |
|---|---|---|
| Ennovate® Cervical | Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use Receives: Device: posterior stabilization for the cervical spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain
Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".
Measured: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary outcomes (5)
Change of Quality of life
In order to analyze the quality of life of the patients, the 5-dimension 5-level score of EuroQol Group (EQ-5D-5L) is used. The score is self-completed by the patient. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Change of Neurological status
The Japanese Orthopaedic Association (JOA) myelopathy score is a disease-specific and physician oriented system that mainly assesses the neurological status of the patient and enables surgeons to compare the changes in the neurological status of the patient before and after certain treatments. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health (physical and mental health), which can be affected by cervical myelopathy.
Measured: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Change of Disability
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
Measured: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Bone fusion
After cervical stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.
Measured: at final follow-up 12 months postoperatively
Cumulative number of side effects
Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.
Measured: throughout the follow-up up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Jul 2021
- Primary completionAug 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FractureStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296889
- Sponsor's protocol ID
- AAG-O-H-2010
- Acronym
- CERISE
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
- ClinicalTrials.gov ID
- NCT05296889
- Acronym / sponsor ID
- CERISE / AAG-O-H-2010
- Conditions
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor, Degenerative Myelopathy
- Keywords
- Cervical Spine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- Raylytic GmbH
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Mar 2022 (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.
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
Detailed description
This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ennovate® Cervical | – | Device: posterior stabilization for the cervical spineAlll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use: fractures, degenerative instability, post-trauma instability, tumors, degenerative cervical myelopathy
Key inclusion criteria (4 listed)
- Patient is minimum 18 years old
- Informed Consent in the documentation of clinical and radiological results
- Patient has indication according to Instructions for Use (IFU)
- Patient is not pregnant
Key exclusion criteria (1 listed)
- Patient's clear unability or unwillingness to participate in follow-up examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterior stabilization for the cervical spineThe Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine. | Device | Ennovate® Cervical |
Primary outcome
Change of Pain
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".
5 secondary outcomes
Change of Quality of life
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Change of Neurological status
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Change of Disability
Time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Bone fusion
Time frame: at final follow-up 12 months postoperatively
Cumulative number of side effects
Time frame: throughout the follow-up up to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fracture and Degenerative Disc Disease, run by Aesculap AG at 4 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 4 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Mattes (+497461950, sarah.mattes@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain (time frame: preoperatively, at 3 months postoperatively and at 12 months postoperatively). 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 3 Aug 2026.