Spondylodesis Musculoskeletal Diseases Spondylodesis
Conditions
Interventions
Participants are randomised to one of two groups in a 1:1 ratio using a randomisation list.
Group 1: Participants receive a lumbar decompression and fusion with a medialized cortical bone trajectory
Sponsors
Medical University of Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical signs of lumbar degenerative stenotic disease from L1 to S1 2. MRI and CT confirmed: central canal stenosis OR lateral recesses stenosis OR foraminal stenosis leading to: 2.1. Radiculopathy, defined as pain and/or motor weakness or paralysis and/or paraestethica in a at least one specific nerve root distribution from L1 to S1 or 2.2. Neurogenic intermittent claudication, defined as pain and/or weakness and/or abnormal sensation in the legs during walking or prolonged standing 3. Indicating decompressive surgery and instrumented mono-, bi- or trisegmental spondylodesis with posterior instrumented fusion system and an intervertebral cage (TLIF) 4. Unresponsive to non-operative treatment for a minimum of 3 months including at least physiotherapy, pain medication and local infiltration therapy 5. Presence of progressive symptoms or signs of nerve root and/or spinal cord compression although performing conservative treatment 6. Aged between 18 and 85 years
Exclusion criteria
Exclusion criteria: 1. Previous surgery: Any instrumented lumbar spinal surgery, cervical and/or thoracic spinal disease to the extent that surgical consideration is likely or anticipated within 6 months after the lumbar surgical treatment 2. Other degenerative joint diseases (i.e. shoulder, hip knee) to the extent that surgical consideration is likely or anticipated within 6 months after or before the lumbar surgical treatment 3. Any other physical diseases (e.g. neuromuscular disorders) before and/or within 6 months after lumbar surgical intervention which are able to restrict study procedures (i.e. wheelchair bound) or preclude accurate clinical examination or outcome 4. Adipositas, severe obesity (BMI > 35 kg/m2) 5. Neoplasia as the source of symptoms 6. Fixed or permanent neurological deficit unrelated to the lumbar spine disease 7. Active or chronic infection, systemic or local, including HIV, AIDS, Hepatitis 8. Active malignancy defined as a history of any invasive malignancy, except non-melanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years 9. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis) 10. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) 11. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin 12. Recent or current history of substance abuse (drugs, alcohol, narcotics, recreational drugs) 13. Known allergy to titanium, Carbon/PEEK and tantalum or intolerance to any device material)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall success is measured using the oswestry disability index (ODI) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression is measured using the Beck depression inventory (BDI) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 2. Pain, back specific function, work disability and patient´s satisfaction are measured using The Core Outcome Measures Index (COMI) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 3. Generic health status is assessed with the EuroQoL-5Dimension (EQ-5D) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 4. Neuropathic pain components are measured the painDETECT questionnaire (PD-Q) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 5. Physical ability of walking is measured using the timed up and go (TUG) test at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 6. Pain relief is measured using a 100 mm visual analoge scale (VAS) at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 7. Lumbar back pain is measured using Quantitaitve sensory testing at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 8. IL-6, TNF alpha, CRP and Leucocyte levels are measured using blood testing at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery 9. Degeneration of treatment levels as well of the adjacent discs is measured using MRI of the lumbar spine at baseline, 24 and 60 months after surgery 10. Degeneration of the treatment level as well of the adjacent lumbar discs is measured ad baseline and overall fusion rate is detected 12 months after surgery using CT of the lumbar spine. 11. Sagittal alignment or possible adjacent disc disease will be assessed using x-ray at baseline, 3 days and 3, 6, 12, 24, 36, 48 and 60 months after surgery. 12. Adverse events will be documented by the clinical team continuously until 60 months post-surgery 13. Intraoperative parameters (blood loss, time of surgery) will be documented throughout surgery | — |
Countries
Austria
Outcome results
None listed