RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis
• Intervention / Treatment: Procedure: RPE-P/TLIF

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Guangdong Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

RPE-P/TLIF; The clinical manifestation is intermittent claudication accompanied by lower back pain. Patients with lumbar spinal canal stenosis indicated by MRI and/or CT, and instability of the responsible segment of the lumbar spine shown by X-ray in the over extension and over flexion position, with severe symptoms that affect daily life and work, and poor conservative treatment effect, should undergo RPE-P/TLIF single or double segment surgical treatment.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
fusion rate	Imaging evaluation indicators:	Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery
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

Collaborators and Investigators

• Sponsor: Wen-xi Sun
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Yong-peng Lin, dr, Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: TF2018-001-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are considering sharing our IPD after the data statistics are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No