In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). The investigators interest is the continuous improvement of the surgical procedure in the context of degenerative cervical spine diseases. Patient satisfaction, as well as the avoidance of possible complications, are the main focus here. In addition, CE-certified medical devices must be evaluated for long-term performance and safety in clinical practice in accordance with the Medical Devices Act. The VERTICALE® Cervical System is a rod-screw system for immobilization (= immobilization) and stabilization of the affected segments, in the area between the occiput, the cervical spine and the upper thoracic spine (up to the 3rd thoracic vertebral body). Surgical intervention with the VERTICALE® Cervical System is performed from behind (posteriorly) and usually serves to stiffen the affected areas. The goals of surgical intervention depend on the exact clinical picture and the associated symptoms, but usually consist of surgical relief of the affected structures of the nervous apparatus and/or spinal cord, stabilization of the bony structures to restore and/or maintain function, and relief of pain.
Study Type
OBSERVATIONAL
Enrollment
20
All measures and devices mentioned in the study protocol correspond to routine clinical practice with the exception of the following questionnaires: NDI (Neck Disability Index) NRS (Numerical Rating Scale) neck pain (cervical spine) and NRS arm pain mJOA (modified Japanese Orthopaedic Association) Score
University of Illinois Hospital and Health Sciences System - UI Health
Chicago, Illinois, United States
RECRUITINGChange of Neck Disability Index (NDI) preoperative (pre-op) compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
The primary endpoint for this PMCF (Post-Market Clinical Follow-Up) study will be the PROM (Patient-reported Outcome Measurement) instrument Neck Disability Index (NDI). This questionnaire is scientifically accepted. \[1\] The aim is to show an improvement of the NDI in comparison pre-op to post-op (12 months follow-up (± 1 month)). The reference for the primary endpoint NDI is a 2008 publication by Hovard Vernon, "The Neck Disability Index: State-of-the-Art, 1991-2008." \[1\] This comparative overview is referenced several times in other publications and represents the SoTA.
Time frame: pre-op compared to 3 month (± 1 month) and 12 months follow-up (± 1 month)
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Time frame: intra-op
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Time frame: Hospital discharge
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Time frame: 3 month (± 1 month)
Documentation of Complications
Documentation of Complications if any occurred incl. classification in relation to implant and manifestation
Time frame: 12 months follow-up (± 1 month)
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Time frame: pre-op
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Time frame: 3 month (± 1 month)
Examination of clinical performance
Evaluation by means of X-ray images and, if necessary, supplementary sectional imaging (CT or MRT)
Time frame: optional: 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of arm/shoulder pain using a Numerical Rating Scale
Documentation of change in pain measured with theNumerical Rating Scale for arm/shoulder pain (0 = no pain; 10 = Unbearable pain).
Time frame: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: Change of neck pain using a Numerical Rating Scale
Documentation of change in pain measured with the Numerical Rating Scale for neck pain (0 = no pain; 10 = Unbearable pain).
Time frame: pre-op compared to post-op (3 month (± 1 month) and 12 months follow-up (± 1 month))
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Time frame: pre-op
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Time frame: 3 month (± 1 month) and 12 months follow-up (± 1 month)
Device effectiveness/patient satisfaction: modified Japanese Orthopaedic Association (mJOA) score for the assessment of a possibly present myelopathy.
Acquisition of the mJOA score for the assessment of a possibly present myelopathy. (Range 0-18 Points; 18 points = no myelopathy; 15-17 points = mild myeolopathy; 12-14 points = moderate myelopathy; 0-11 Points = severe myelopathy;
Time frame: 12 months follow-up (± 1 month)
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