Clinical trial NCT06290908: RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Official title: Robot-assisted Percutaneous Endoscopic Posterior/Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis With Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Lead sponsor: Guangzhou University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2024-03-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included patients with clinical manifestations of 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 responsible segment lumbar instability. Symptoms were severe, affecting daily life and work, and conservative treatment was ineffective. RPE-P/TLIF single or double segment surgery was performed.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain visual analog scale (VAS)
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary outcomes:
measure: Oswestry disability index (ODI)
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
measure: MacNab criteria
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
measure: intervertebral space height
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
measure: lumbar physiological curvature
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
measure: fusion rate
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
measure: pedicle screw accuracy
timeFrame: Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Yong-peng Lin, dr
role: STUDY_CHAIR
References: