Clinical and radiological effect of cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis

Medical University of Innsbruck0 sites154 target enrollmentDecember 3, 2016

Overview

Registry

who.int

Start Date

December 3, 2016

End Date

December 31, 2024

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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)