Spinal Stenosis
Conditions
Brief summary
Objective To analyze the effectiveness and safety of robot-assisted percutaneous endoscopic posterior/transforaminal lumbar interbody fusion (RPE-P/TLIF) in the treatment of lumbar spinal stenosis with instability. Methods A single-center prospective study from September 2018 to April 2022, patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF. Pain visual analog scale (VAS) was used to evaluate the degree of low back pain and lower limb pain before operation, 1 month, 6 months, 1 year after operation and at the final follow-up, and the Oswestry disability index (ODI) was used to evaluate the degree of lumbar spinal function. At the last follow-up, MacNab criteria were used to evaluate the clinical efficacy. Imaging evaluation included the measurement of intervertebral space height, lumbar physiological curvature, fusion rate and pedicle screw accuracy by preoperative and lateral X-ray films.
Interventions
PROCEDURERPE-P/TLIF
patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Wen-xi Sun
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who present with intermittent claudication accompanied by lower back pain, lumbar spine MRI and/or CT findings of lumbar spinal stenosis, and X-ray images of over extension and over flexion indicating instability of the responsible segment of the lumbar spine, have severe symptoms that affect daily life and work, and have poor conservative treatment results. Therefore, RPE-P/TLIF single segment or double segment surgical treatment is recommended.
Exclusion criteria
(1) Simple lumbar spinal stenosis without responsible segment instability; (2) Long segment (3 or more) spinal stenosis with lumbar instability; (3) Patients with major internal medicine underlying diseases who cannot tolerate surgery; (4) Individuals with comorbid mental disorders or Alzheimer's disease who are unable to cooperate with relevant scale filling and subsequent follow-up; (5) Age\<18 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain visual analog scale (VAS) | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Pain assessment, assessing lower back pain and lower limb pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MacNab criteria | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | The overall efficacy rate was evaluated using the modified MacNab criteria, which were divided into four levels: excellent, good, fair, and poor. Among them, excellent was the complete disappearance of symptoms and the restoration of normal life; Liangwei still has mild symptoms and mild activity restriction, but has no impact on life and work; May still have obvious symptoms, limited activities, and affect normal life and work; Poor symptoms do not improve, activities do not improve, and even worsen. |
| intervertebral space height | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Imaging evaluation indicators: |
| Oswestry disability index (ODI) | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Evaluate neurological function |
| fusion rate | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Imaging evaluation indicators: |
| pedicle screw accuracy | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Imaging evaluation indicators: |
| lumbar physiological curvature | Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery | Imaging evaluation indicators: |
Countries
China
Outcome results
None listed