RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

Spinal Stenosis Clinical Trial

Official title:

Robot-assisted Percutaneous Endoscopic Posterior/Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis With Instability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290908
• Other study ID #: TF2018-001-01
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Guangzhou University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 1, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

Procedure:
• RPE-P/TLIF
patients with lumbar spinal stenosis and instability who met the inclusion and exclusion criteria were treated with RPE-P/TLIF

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Wen-xi Sun	Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain visual analog scale (VAS)	Pain assessment, assessing lower back pain and lower limb pain.	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	Oswestry disability index (ODI)	Evaluate neurological function	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	MacNab criteria	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.	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	intervertebral space height	Imaging evaluation indicators:	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	lumbar physiological curvature	Imaging evaluation indicators:	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	fusion rate	Imaging evaluation indicators:	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
Secondary	pedicle screw accuracy	Imaging evaluation indicators:	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery