An observational study in Degenerative Disc Disease, Spondylolisthesis and Trauma, sponsored by Aesculap AG. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Aesculap AG (part of B. Braun) · 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 11th largest by 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 20th 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: 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 enrollment of 60 is below 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:
Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Aesculap AG has 6 studies 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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Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation
adult patients
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.
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.
Clinical Results measured by Neck Disability Index (NDI)
The 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.
Time frame: One retrospective visit, between one and approx. five years post-op.
Neck and arm pain
Visual analogue scale for pain: The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain ever with a frowning face image.
Time frame: One retrospective visit, between one and approx. five years post-op.
Patient satisfaction
Patient satisfaction with Outcome of surgery documented in two aspects: is the Patient satisfied (four Point scale: very satisfied, satisfied, unsatisfied, very unsatisfied) and would the Patient like to undergo surgery again (yes, no, not willing to say)
Time frame: One retrospective visit, between one and approx. five years post-op.
Quality of life measured by EQ-5D-5L
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.
Time frame: One retrospective visit, between one and approx. five years post-op.
Dysphagia assessment
Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none
Time frame: One retrospective visit, between one and approx. five years post-op.
Complications
Adverse Events and Serious Adverse Events, reoperations and revisions rates
Time frame: One retrospective visit, between one and approx. five years post-op.
Postoperative Need for Pain medication
The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder
Time frame: One retrospective visit, between one and approx. five years post-op.
Radiological outcome from standard x-rays
Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines
Time frame: One retrospective visit, between one and approx. five years post-op.
Ran from Nov 2019 to primary completion in Feb 2020, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →