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 · Observational
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
Exclusion Criteria:
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.
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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Aesculap AG