RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

NCT06290908 | Completed

• 1 other identifier: TF2018-001-01
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Oswestry disability index (ODI)

  Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery

• MacNab criteria

  Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery

• intervertebral space height

  Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery

• lumbar physiological curvature

  Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery

• fusion rate

  Before surgery, 1 month after surgery, 6 months after surgery, 1 year after surgery, and 4 years after surgery

Study Arms (1)

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

Interventions

RPE-P/TLIF PROCEDURE

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

RPE-P/TLIF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wen-xi Sun: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, China

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Yong-peng Lin, dr

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 4, 2024
• Study Start: September 4, 2018
• Primary Completion: April 30, 2022
• Study Completion: February 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

CN (1)