Degenerative Disc DiseaseNCT03956537
PMCF Neo Pedicle Screw and Cage Systems
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Neo Medical SA at 2 sites in 2 countries.
Trial summary
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- NEO Pedicle Screw System™ and Neo Cage System™
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Oct 2019to 31 Oct 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: In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2).
Who may be able to join
- Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
- Patient has participated in or is willing to participate in the routine postoperative follow-up program
- Patient is willing to provide written informed consent
Who cannot join
- Patient is under the age of 18 or skeletally immature
- Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch
Sande, 26452
About this study
Official title: Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor, Trauma, Pseudoarthrosis of Spine
- Being tested
- NEO Pedicle Screw System™, Neo Cage System™
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Stenosis, Spinal Cord Neoplasms, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEO Pedicle Screw System™Device
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
Neo Cage System™Device
Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™
| Study group | Role | What they receive |
|---|---|---|
| Pedicle screw system alone | Not described Receives: Device: NEO Pedicle Screw System™ | |
| Pedicle screw system with cages | Not described Receives: Device: NEO Pedicle Screw System™; Device: Neo Cage System™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient´s function from baseline to 12 months
Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: 12 months
The rate of cage migration in cage-plus-screw systems.
Defined as posterior movement of the cage past the posterior wall of the vertebral body.
Measured: 12 months and 24 months post operatively
The rate of pedicle screw loosening in screw only and cage-plus-screw systems.
A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs
Measured: 12 months and 24 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Oct 2019
- Primary completion31 Jan 2025
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neo Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ConfinisCPM
- Responsible party
- Sponsor
- Investigators
- David C Noriega, PhD, MD, Principal investigator, Spine Center, University Hospital Valladolid, Valladolid, SpainYasser Abdalla, MD, Principal investigator, Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956537
- Sponsor's protocol ID
- NeoPMCF01
- Status last verified
- Jun 2025
- First submitted
- 16 May 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion With the Neo Pedicle Screw and Cage Systems: A Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT03956537
- Acronym / sponsor ID
- NeoPMCF01
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor, Trauma, Pseudoarthrosis of Spine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Neo Medical SAIndustry (pharma, biotech, devices)
- Collaborators
- ConfinisCPM
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 20 May 2019 (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 objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedicle screw system alone | – | Device: NEO Pedicle Screw System™ |
| Pedicle screw system with cages | – | Device: NEO Pedicle Screw System™, Device: Neo Cage System™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In total, approximately 150 patients will be recruited and enrolled to ensure that at least 132 patients are evaluable at 12 and 24 months. Patients are recruited consecutively, retrospectively as well as prospectively. The potential patients to be recruited have either already been implanted or are planned to be implanted with the Neo Pedicle Screw System (Arm 1) or Neo Cage System and Neo Pedicle Screw System (Arm 2).
Key inclusion criteria (3 listed)
- Patient has undergone or is intended to undergo surgery with the Neo Pedicle Screw System™, standalone or in combination with the Neo Cage System™, for any of the approved indications as defined in the respective labelling
- Patient has participated in or is willing to participate in the routine postoperative follow-up program
- Patient is willing to provide written informed consent
Key exclusion criteria (2 listed)
- Patient is under the age of 18 or skeletally immature
- Patient had or has a contraindication to surgery or to any of the implant systems used in the study, as defined in the respective labelling
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 |
|---|---|---|
| NEO Pedicle Screw System™The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. | Device | Pedicle screw system alone, Pedicle screw system with cages |
| Neo Cage System™Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™ | Device | Pedicle screw system with cages |
Primary outcome
Change in patient´s function from baseline to 12 months
Time frame: 12 months
Clinical outcome in function as measured by the 100 point Oswestry Disability Index (ODI). Zero is equated with no disability and 100 is the maximum disability possible.
The rate of cage migration in cage-plus-screw systems.
Time frame: 12 months and 24 months post operatively
Defined as posterior movement of the cage past the posterior wall of the vertebral body.
The rate of pedicle screw loosening in screw only and cage-plus-screw systems.
Time frame: 12 months and 24 months post operatively
A radiolucent zone, >1mm, surrounding the pedicle screw seen in radiograhs
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 13 Jun 2025.
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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.
David C Noriega, PhD, MD principal investigator
Spine Center, University Hospital Valladolid, Valladolid, Spain
Yasser Abdalla, MD principal investigator
Dep. of Neurosurgery, Nordwest Krankenhaus Sanderbusch, Sande, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Neo Medical SA at 2 sites in 2 countries.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. 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?
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 in patient´s function from baseline to 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. 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 13 Jun 2025.