Quintex® Follow-up After One Year Minimum

Study Overview
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Brief Summary
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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

Official Title
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Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year

Conditions
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Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis, Deformity of Spine, Pseudoarthrosis of Spine, Cervical Spondylosis, Instability; Back

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One retrospective visit, between one and approx. five years post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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 | One retrospective visit, between one and approx. five years post-op. | 
| Complications | Adverse Events and Serious Adverse Events, reoperations and revisions rates | 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 | 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 | One retrospective visit, between one and approx. five years post-op. |