Cervical Spondylosis, Deformity of Spine, Degenerative Disc Disease, Instability; Back, Pseudoarthrosis of Spine, Spinal Stenosis, Spondylolisthesis, Trauma
Conditions
Brief 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
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Results measured by Neck Disability Index (NDI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | One retrospective visit, between one and approx. five years post-op. | 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) |
| Quality of life measured by EQ-5D-5L | One retrospective visit, between one and approx. five years post-op. | 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. |
| Dysphagia assessment | One retrospective visit, between one and approx. five years post-op. | Bazaz score: The Bazaz Dysphagia Score is one criterion used to define dysphagia; it classifies dysphagia as severe, moderate, mild, or none |
| Neck and arm pain | 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. |
| Postoperative Need for Pain medication | One retrospective visit, between one and approx. five years post-op. | The patient's Need for Pain Medication is measured by the WHO (World Health Organization) analgesic ladder |
| Radiological outcome from standard x-rays | One retrospective visit, between one and approx. five years post-op. | Radiologically: Fusion status, plate position, pot. migration of screws and plate, radiolucent lines |
| Complications | One retrospective visit, between one and approx. five years post-op. | Adverse Events and Serious Adverse Events, reoperations and revisions rates |
Countries
Germany
Outcome results
None listed