An observational study in Degenerative Disc Disease, Spondylolisthesis and Spinal Stenosis, sponsored by Neo Medical SA. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Neo Medical SA · Observational
Among 29 studies in Intervertebral Disc Degeneration with a site in Germany — 4 open to participants now, 9 under way, 1 of them phase 3. Intervertebral Disc Degeneration · Germany.
Among the 29 studies in Intervertebral Disc Degeneration with a site in Germany, this one is the 6th largest by planned enrollment of the 18 observational ones that give a count, is one of 8 that started in 2019, is one of 18 observational ones, and was the 18th registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
Browse Intervertebral Disc Degeneration studies →4 of the 29 studies in Intervertebral Disc Degeneration with a site in Germany are open now. Recruiting first, the newest first:
Aesculap AG · Sites in Germany
Medacta International SA · Sites in Germany
BACKBONE · Sites in Germany, Denmark, France
Centinel Spine · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 8 started in 2019.
This study's planned enrollment of 150 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Median enrollment 70 across the 10 interventional studies, 72 across the 18 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 29 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Neo Medical SA as lead sponsor.
Neo Medical SA has 1 study filed under Intervertebral Disc Degeneration — fewer than ten, so there is no comparison to draw.
2 of the studies in Intervertebral Disc Degeneration with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05631392Invibio LtdStudy to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion | 2027-06 |
| NCT05296889Aesculap AGPost-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical | 2027-08 |
Among the 29 studies in Intervertebral Disc Degeneration with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: NEO Pedicle Screw System™
Device: NEO Pedicle Screw System™ · Device: Neo Cage 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.
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™
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.
Time frame: 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.
Time frame: 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
Time frame: 12 months and 24 months post operatively
Ran from Oct 2019 to primary completion in Jan 2025, 63 months.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's 63 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →