Degenerative Disc Disease (DDD)NCT05489822
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
An observational study of Degenerative Disc Disease (DDD) and Instabilities, run by Silony Medical GmbH at 1 site in United States.
Trial summary
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease (DDD), Instabilities, Trauma
- What is being tested?
- VERTICALE® Cervical System
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 30 Nov 2024
- 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: Patients (minimum 18 years old) who undergo surgery with the VERTICALE® Cervical System due to one or a combination of the above mentioned indications and give their written consent to participate.
Who may be able to join
- Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations
- The surgical indication must be one or a combination of the following
- Degenerative disc disease (DDD)
- Instabilities
- Trauma
- Deformities
Show all 9Show fewer
- Mono-, bi- and multisegmental restoration (occipital T3)
- Age: ≥ 18 years
- The subject must give written informed consent before inclusion into the PMCF study.
Who cannot join
- Relative and absolute contraindications according to IFU (Instruction for Use):
- Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it.
- These include in particular:
- Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium).
- Active systemic infection or an infection localized to the site of the proposed implantation
- Any case in which the chosen implants would be too large or too small to achieve a successful result.
- Any patient for whom the use of the implant would conflict with anatomical structures.
- Missing bony structures, which would render solid anchoring of the implant impossible (e.g., in the case of fractures, tumors, or osteoporosis). In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital and Health Sciences System - UI Health
Chicago, Illinois, 60612
About this study
Official title: Sponsor-initiated, Prospective, Single-center, Non-interventional Clinical Observational Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3).
Read more
Primary Objective:
To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire.
Primary endpoint hypothesis:
The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Read the detailed description
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3).
The investigators interest is the continuous improvement of the surgical procedure in the context of degenerative cervical spine diseases. Patient satisfaction, as well as the avoidance of possible complications, are the main focus here. In addition, CE-certified medical devices must be evaluated for long-term performance and safety in clinical practice in accordance with the Medical Devices Act. The VERTICALE® Cervical System is a rod-screw system for immobilization (= immobilization) and stabilization of the affected segments, in the area between the occiput, the cervical spine and the upper thoracic spine (up to the 3rd thoracic vertebral body). Surgical intervention with the VERTICALE® Cervical System is performed from behind (posteriorly) and usually serves to stiffen the affected areas.
The goals of surgical intervention depend on the exact clinical picture and the associated symptoms, but usually consist of surgical relief of the affected structures of the nervous apparatus and/or spinal cord, stabilization of the bony structures to restore and/or maintain function, and relief of pain.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Being tested
- VERTICALE® Cervical System
- Keywords
- NDI
- Medical subject headings
- Intervertebral Disc Degeneration, Wounds and Injuries, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERTICALE® Cervical SystemDevice
All measures and devices mentioned in the study protocol correspond to routine clinical practice with the exception of the following questionnaires:
NDI (Neck Disability Index) NRS (Numerical Rating Scale) neck pain (cervical spine) and NRS arm pain mJOA (modified Japanese Orthopaedic Association) Score
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Neck Disability Index (NDI) preoperative (pre-op) compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
The primary endpoint for this PMCF (Post-Market Clinical Follow-Up) study will be the PROM (Patient-reported Outcome Measurement) instrument Neck Disability Index (NDI). This questionnaire is scientifically accepted. [1] The aim is to show an improvement of the NDI in comparison pre-op to post-op (12 months follow-up (± 1 month)). The reference for the primary endpoint NDI is a 2008 publication by Hovard Vernon, "The Neck Disability Index: State-of-the-Art, 1991-2008." [1] This comparative overview is referenced several times in other publications and represents the SoTA.
Measured: pre-op compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
Secondary outcomes (12)
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Measured: intra-op
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Measured: Hospital discharge
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Measured: 3 month (± 1 month)
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Measured: 12 months follow-up (± 1 month)
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Measured: pre-op
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Measured: 3 month (± 1 month)
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Measured: optional: 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of arm/shoulder pain using a Numerical Rating Scale
Documentation of change in pain measured with theNumerical Rating Scale for arm/shoulder pain (0 = no pain; 10 = Unbearable pain).
Measured: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of neck pain using a Numerical Rating Scale
Documentation of change in pain measured with the Numerical Rating Scale for neck pain (0 = no pain; 10 = Unbearable pain).
Measured: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Measured: pre-op
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Measured: 3 month (± 1 month) and 12 months follow-up (± 1 month)
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Measured: 12 months follow-up (± 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start13 Jan 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The study center was not able to implement the contract parameters to our satisfaction. In particular, the number of patients recruited was far below the number agreed in the PMCF study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc Disease (DDD)Studies of the same condition, open and under way.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silony Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ankit I. Mehta, MD, Principal investigator, University of Illinois Hospital and Health Sciences System - UI Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489822
- Sponsor's protocol ID
- TDII_2014-003_2.1_103
- Status last verified
- May 2026
- First submitted
- 27 Jul 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
PubMed 18803999Kato S, Oshima Y, Oka H, Chikuda H, Takeshita Y, Miyoshi K, Kawamura N, Masuda K, Kunogi J, Okazaki R, Azuma S, Hara N, Tanaka S, Takeshita K. Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study. PLoS One. 2015 Apr 2;10(4):e0123022. doi: 10.1371/journal.pone.0123022. eCollection 2015.
PubMed 25837285
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponsor-initiated, Prospective, Single-center, Non-interventional Clinical Observational Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
- ClinicalTrials.gov ID
- NCT05489822
- Acronym / sponsor ID
- TDII_2014-003_2.1_103
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Keywords
- NDI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study center was not able to implement the contract parameters to our satisfaction. In particular, the number of patients recruited was far below the number agreed in the PMCF study protocol.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Silony Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Aug 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.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3).
Primary Objective:
To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire.
Primary endpoint hypothesis:
The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Detailed description
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3).
The investigators interest is the continuous improvement of the surgical procedure in the context of degenerative cervical spine diseases. Patient satisfaction, as well as the avoidance of possible complications, are the main focus here. In addition, CE-certified medical devices must be evaluated for long-term performance and safety in clinical practice in accordance with the Medical Devices Act. The VERTICALE® Cervical System is a rod-screw system for immobilization (= immobilization) and stabilization of the affected segments, in the area between the occiput, the cervical spine and the upper thoracic spine (up to the 3rd thoracic vertebral body). Surgical intervention with the VERTICALE® Cervical System is performed from behind (posteriorly) and usually serves to stiffen the affected areas.
The goals of surgical intervention depend on the exact clinical picture and the associated symptoms, but usually consist of surgical relief of the affected structures of the nervous apparatus and/or spinal cord, stabilization of the bony structures to restore and/or maintain function, and relief of pain.
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
- Patients (minimum 18 years old) who undergo surgery with the VERTICALE® Cervical System due to one or a combination of the above mentioned indications and give their written consent to participate.
Key inclusion criteria (9 listed)
- Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations
- The surgical indication must be one or a combination of the following
- Degenerative disc disease (DDD)
- Instabilities
- Trauma
Key exclusion criteria (8 listed)
- Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it.
- Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium).
- Active systemic infection or an infection localized to the site of the proposed implantation
- Any case in which the chosen implants would be too large or too small to achieve a successful result.
- Any patient for whom the use of the implant would conflict with anatomical structures.
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 |
|---|---|---|
| VERTICALE® Cervical SystemAll measures and devices mentioned in the study protocol correspond to routine clinical practice with the exception of the following questionnaires: NDI (Neck Disability Index) NRS (Numerical Rating Scale) neck pain (cervical spine) and NRS arm pain mJOA (modified Japanese Orthopaedic Association) Score | Device | – |
Primary outcome
Change of Neck Disability Index (NDI) preoperative (pre-op) compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
Time frame: pre-op compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
The primary endpoint for this PMCF (Post-Market Clinical Follow-Up) study will be the PROM (Patient-reported Outcome Measurement) instrument Neck Disability Index (NDI). This questionnaire is scientifically accepted. [1] The aim is to show an improvement of the NDI in comparison pre-op to post-op (12 months follow-up (± 1 month)). The reference for the primary endpoint NDI is a 2008 publication by Hovard Vernon, "The Neck Disability Index: State-of-the-Art, 1991-2008." [1] This comparative overview is referenced several times in other publications and represents the SoTA.
12 secondary outcomes
Documentation of Complications
Time frame: intra-op
Documentation of Complications
Time frame: Hospital discharge
Documentation of Complications
Time frame: 3 month (± 1 month)
Documentation of Complications
Time frame: 12 months follow-up (± 1 month)
Examination of clinical performance
Time frame: pre-op
Examination of clinical performance
Time frame: 3 month (± 1 month)
Examination of clinical performance
Time frame: optional: 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of arm/shoulder pain using a Numerical Rating Scale
Time frame: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of neck pain using a Numerical Rating Scale
Time frame: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Time frame: pre-op
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Time frame: 3 month (± 1 month) and 12 months follow-up (± 1 month)
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Time frame: 12 months follow-up (± 1 month)
Results and safety
The study was stopped early (reason given: The study center was not able to implement the contract parameters to our satisfaction. In particular, the number of patients recruited was far below the number agreed in the PMCF study protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 18803999Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.
- Background: PubMed 25837285Kato S, Oshima Y, Oka H, Chikuda H, Takeshita Y, Miyoshi K, Kawamura N, Masuda K, Kunogi J, Okazaki R, Azuma S, Hara N, Tanaka S, Takeshita K. Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study. PLoS One. 2015 Apr 2;10(4):e0123022. doi: 10.1371/journal.pone.0123022. eCollection 2015.
- 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. This study is not recruiting at the moment.
Ankit I. Mehta, MD principal investigator
University of Illinois Hospital and Health Sciences System - UI Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease (DDD) and Instabilities, run by Silony Medical GmbH at 1 site in United States.
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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: The study center was not able to implement the contract parameters to our satisfaction. In particular, the number of patients recruited was far below the number agreed in the PMCF study protocol.). Results are not available in the source record.
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 Neck Disability Index (NDI) preoperative (pre-op) compared to 3 month (± 1 month) and 12 months follow-up (± 1 month) (time frame: pre-op compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05489822, which also lists 2 linked publications.
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 11 May 2026.