- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489394
Quintex® Follow-up After One Year Minimum (Quintex)
Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Koblenz, Germany, 56073
- Katholisches Klinikum Koblenz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient informed consent not signed
- Patients living outside a radius of 80 km around the study center
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One retrospective visit, between one and approx. five years post-op.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck and arm pain
Time Frame: One retrospective visit, between one and approx. five years post-op.
|
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.
|
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.
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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) |
One retrospective visit, between one and approx. five years post-op.
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Quality of life measured by EQ-5D-5L
Time Frame: One retrospective visit, between one and approx. five years post-op.
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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.
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One retrospective visit, between one and approx. five years post-op.
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Dysphagia assessment
Time Frame: One retrospective visit, between one and approx. five years post-op.
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Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none
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One retrospective visit, between one and approx. five years post-op.
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Complications
Time Frame: One retrospective visit, between one and approx. five years post-op.
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Adverse Events and Serious Adverse Events, reoperations and revisions rates
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One retrospective visit, between one and approx. five years post-op.
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Postoperative Need for Pain medication
Time Frame: One retrospective visit, between one and approx. five years post-op.
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The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder
|
One retrospective visit, between one and approx. five years post-op.
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Radiological outcome from standard x-rays
Time Frame: One retrospective visit, between one and approx. five years post-op.
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Radiologically: Fusion status, plate position, pot.
migration of screws and plate, radiolucent lines
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One retrospective visit, between one and approx. five years post-op.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAG-O-H-1901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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