M48.02
Conditions
Interventions
Group 1: The aim of the study is to analyze safety, feasibility and efficacy for spinal canal decompression in patients undergoing minimal invasive arcocristectomy.
Sponsors
Uniklinikum Freiburg, Klinik für Neurochirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Included are all patients with a surgical indication for minimally invasive arcocristectomy. Indications for minimally invasive arcocristectomy are:(a) Symptomatic spinal stenosis with predominantly posterior spinal cord compression (b) mJOA score 18 years and ability to give informed consent. (d) Written informed consent from the patient.
Exclusion criteria
Exclusion criteria: a) Instability of the affected segment b) Kyphotic deformity in the affected segment c) MRI exclusion criteria (see standardized MRI information sheet). d) Patients with previous cervical surgery at the level of spinal stenosis. e) Non-degenerative causes of associated symptomatology (tumor, inflammation/infection, trauma). f) Severe underlying internal disease g) The following central neurological or psychiatric diseases: severe stroke, advanced dementia, Parkinson's disease, multiple sclerosis or comparable CNS inflammatory disease, severe depression, severe schizoaffective disorder. h) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of myelopathy defined by mJOA score preoperative, after three and after twelve months to evaluate the clinical course. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Sufficient decompression of the cervical spinal canal through a minimal invasive arcocristectomy measured volumetrically at the level of the addressed stenosis on postoperative MRI. Cervical spinal canal decompression is defined as dichotomous variable and achieved, when cerebral spinal fluid signal (CSF) is visible again around the spinal cord on MR images. b) Clinical course preoperative, after three and after twelve months (pain level (NRS), NDI, Nurick grading, McCormick score, Karnofsky-Index, subjective range of motion) c) Major complications within 30 days after surgery (death, ACS, pulmonary embolism, stroke, ventilation-required pneumonia, revision surgery, new severe motoric deficit MRC = 3/5) d) Minor complications within 30 days after surgery (deep vein thrombosis, non-ventilation-required pneumonia, urinary tract infection, transfusion-required anemia, wound healing disturbance/infection, CSF fistula, new slightly motoric deficit MRC > 3/5, new sensory deficit) e) Long-term complications within one year (secondary surgery, instability/secondary stabilization) f) Objective cervical range of motion preoperative, after three and after twelve months (CROM device) g) Change of intramedullary MRI signal alterations after surgery (T1/T2, Microstructural Diffusion-based Imaging, MR spectroscopy) | — |
Countries
Germany
Contacts
Public ContactMarco Bissolo
Uniklinikum Freiburg
Outcome results
None listed