Degenerative Disc DiseaseQuintexNCT04489394
Quintex® Follow-up After One Year Minimum
An observational study of Degenerative Disc Disease and Spondylolisthesis, run by Aesculap AG at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Trauma
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2019to 18 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: adult patients
Who may be able to join
- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center
Who cannot join
- Patient informed consent not signed
- Patients living outside a radius of 80 km around the study center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
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
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis, Deformity of Spine, Pseudoarthrosis of Spine
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Wounds and Injuries, Spinal Stenosis, Spondylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One retrospective visit, between one and approx. five years post-op.
Secondary outcomes (7)
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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: One retrospective visit, between one and approx. five years post-op.
Complications
Adverse Events and Serious Adverse Events, reoperations and revisions rates
Measured: 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
Measured: 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
Measured: One retrospective visit, between one and approx. five years post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start11 Nov 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489394
- Sponsor's protocol ID
- AAG-O-H-1901
- Acronym
- Quintex
- Status last verified
- Apr 2024
- First submitted
- 24 Jul 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruchmann B, Kilian F. Follow-up of a new titanium cervical plate for fusion of the cervical spine. Orthop Rev (Pavia). 2023 Oct 12;15:84651. doi: 10.52965/001c.84651. eCollection 2023.
PubMed 37842541
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
- ClinicalTrials.gov ID
- NCT04489394
- Acronym / sponsor ID
- Quintex / AAG-O-H-1901
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis, Deformity of Spine, Pseudoarthrosis of Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 28 Jul 2020 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (1 listed)
- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center
Key exclusion criteria (2 listed)
- Patient informed consent not signed
- Patients living outside a radius of 80 km around the study center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Results measured by Neck Disability Index (NDI)
Time frame: One retrospective visit, between one and approx. five years post-op.
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.
7 secondary outcomes
Neck and arm pain
Time frame: One retrospective visit, between one and approx. five years post-op.
Patient satisfaction
Time frame: One retrospective visit, between one and approx. five years post-op.
Quality of life measured by EQ-5D-5L
Time frame: One retrospective visit, between one and approx. five years post-op.
Dysphagia assessment
Time frame: One retrospective visit, between one and approx. five years post-op.
Complications
Time frame: One retrospective visit, between one and approx. five years post-op.
Postoperative Need for Pain medication
Time frame: One retrospective visit, between one and approx. five years post-op.
Radiological outcome from standard x-rays
Time frame: One retrospective visit, between one and approx. five years post-op.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Results publication: PubMed 37842541Bruchmann B, Kilian F. Follow-up of a new titanium cervical plate for fusion of the cervical spine. Orthop Rev (Pavia). 2023 Oct 12;15:84651. doi: 10.52965/001c.84651. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Spondylolisthesis, run by Aesculap AG at 1 site 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 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: finished, as of the sponsor's last update on 9 Apr 2024. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Results measured by Neck Disability Index (NDI) (time frame: One retrospective visit, between one and approx. five years post-op.). 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 NCT04489394, which also lists 1 linked publication.
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 9 Apr 2024.