Cervical Spine DiseaseMISPECNCT06960018
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
A study testing Ennovate® Cervical, open surgical technique and Ennovate® Cervical, minimal invasive surgical technique in people with Cervical Spine Disease and Pain, Postoperative, run by Aesculap AG at 3 sites in Germany.
Trial summary
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spine Disease, Pain, Postoperative
- What is being tested?
- Ennovate® Cervical, open surgical technique and Ennovate® Cervical, minimal invasive surgical technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesGermany
- Study dates
- 20 Jun 2025to Nov 2028
- Phase
- Interventional
- 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
Who may be able to join
- All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the restoration and stabilization of the cervical spine
Who cannot join
- All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded.
- Absolute contraindications according to the IFU:
- Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc.
- Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system.
- Suspected allergy or sensitivity to the implant materials.
- Acute or chronic vertebral infections of a local or systemic nature.
- Poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, 52074
Christian Blume, Dr.med.
- Recruiting
Charité Berlin
Berlin, 10117
Peter Vajkozcy, Prof.
004930 45050
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 70196
Jan-Helge Klingler, Prof.Dr.med, jan-helge.klingler@uniklinik-freiburg.de
About this study
Official title: Controlled, Randomized Clinical Study to Demonstrate the Patient Benefit and Safety of Pedicle Screw Placement Through an Innovative Minimally Invasive Surgical Approach Using the Ennovate® Cervical Spinal System
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.
- Conditions
- Cervical Spine Disease, Pain, Postoperative
- Being tested
- Ennovate® Cervical, open surgical technique, Ennovate® Cervical, minimal invasive surgical technique
- Keywords
- posterior cervical fusion, pedicle screw
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ennovate® Cervical, open surgical techniqueDevice
Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of
- Fractures
- Degenerative instability
- Post-trauma instability
- Tumors
- Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using an open surgical technique
Ennovate® Cervical, minimal invasive surgical techniqueDevice
Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of
- Fractures
- Degenerative instability
- Post-trauma instability
- Tumors
- Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using a minimally invasive technique.
| Study group | Role | What they receive |
|---|---|---|
| Implantation Ennovate® Cervical system using an open surgical technique | Active comparator | Not described Receives: Device: Ennovate® Cervical, open surgical technique |
| Implantation Ennovate® Cervical system using a minimally invasive technique. | Experimental | Not described Receives: Device: Ennovate® Cervical, minimal invasive surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.
Measured: 4 (+/- 1 day) postoperative
Secondary outcomes (6)
Screw placement accuracy
Evaluation of the accuracy of screw placement will be performed according to the method described by Bredow using CT/3D-Scans made at intraoperative/discharge visit.
Measured: intraoperative or discharge visit (approx. 10 days post op.)
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a widely used and validated self-assessment tool for measuring disability due to neck pain. (Measured over the course of the study)
- 0-4 (0-8%): No disability
- 5-14 (10-28%): Mild disability
- 15-24 (30-48%): Moderate disability
- 25-34 (50-64%): Severe disability
- 35-50 (70-100%): Complete disability
Measured: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Quality of Life (EQ-5D-5L)
EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Measured: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Quality of Life (EQ-VAS)
EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Measured: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Rate of Adverse Events / Serious Adverse Events
(Serious) Adverse Events During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects ((S)AE) related or not related to the product under investigation, will be documented. The total number of (S)AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product.
Measured: During the course of the study up to two years postoperatively
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.
Measured: praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start20 Jun 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly allocated to one of the two study groups in a 1:1 ratio. In addition, stratification by clinical investigation sites is applied. Group 1: Patients treated with the Ennovate® Cervical system using an open surgical technique. Group 2: Patients treated with the Ennovate® Cervical system using a minimally invasive technique. Study is designed to provide a comparison of the both groups regarding the short-term pain outcome.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960018
- Sponsor's protocol ID
- AAG-O-H-23045
- Acronym
- MISPEC
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 15 Apr 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized Clinical Study to Demonstrate the Patient Benefit and Safety of Pedicle Screw Placement Through an Innovative Minimally Invasive Surgical Approach Using the Ennovate® Cervical Spinal System
- ClinicalTrials.gov ID
- NCT06960018
- Acronym / sponsor ID
- MISPEC / AAG-O-H-23045
- Conditions
- Cervical Spine Disease, Pain, Postoperative
- Keywords
- posterior cervical fusion, pedicle screw
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 7 May 2025 (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.
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated to one of the two study groups in a 1:1 ratio. In addition, stratification by clinical investigation sites is applied. Group 1: Patients treated with the Ennovate® Cervical system using an open surgical technique. Group 2: Patients treated with the Ennovate® Cervical system using a minimally invasive technique. Study is designed to provide a comparison of the both groups regarding the short-term pain outcome.
| Arm | Type | Receives |
|---|---|---|
| Implantation Ennovate® Cervical system using an open surgical technique | Active comparator | Device: Ennovate® Cervical, open surgical technique |
| Implantation Ennovate® Cervical system using a minimally invasive technique. | Experimental | Device: Ennovate® Cervical, minimal invasive surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the restoration and stabilization of the cervical spine
Key exclusion criteria (7 listed)
- All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded.
- Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc.
- Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system.
- Suspected allergy or sensitivity to the implant materials.
- Acute or chronic vertebral infections of a local or systemic nature.
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 |
|---|---|---|
| Ennovate® Cervical, open surgical techniquePatients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using an open surgical technique | Device | Implantation Ennovate® Cervical system using an open surgical technique |
| Ennovate® Cervical, minimal invasive surgical techniquePatients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using a minimally invasive technique. | Device | Implantation Ennovate® Cervical system using a minimally invasive technique. |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 4 (+/- 1 day) postoperative
Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain". Pain will be recorded at minimum 12 months postoperatively, if available in the preoperative clinical routine data, it will also be recorded in the study.
6 secondary outcomes
Screw placement accuracy
Time frame: intraoperative or discharge visit (approx. 10 days post op.)
Neck Disability Index (NDI)
Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Quality of Life (EQ-5D-5L)
Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Quality of Life (EQ-VAS)
Time frame: praeoperative, postoperative (4 days +/- 1day, 2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
Rate of Adverse Events / Serious Adverse Events
Time frame: During the course of the study up to two years postoperatively
Visual Analogue Scale (VAS)
Time frame: praeoperative, postoperative (2 weeks, 4 weeks, 6 weeks, 3 months, 1 year, 2 years)
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 15 Apr 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ennovate® Cervical, open surgical technique and Ennovate® Cervical, minimal invasive surgical technique in people with Cervical Spine Disease and Pain, Postoperative, run by Aesculap AG at 3 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 7 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (+497461 ext. 0, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 4 (+/- 1 day) 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 15 Apr 2026.