Clinical Trials Directory

Trials / Completed

CompletedNCT06290908

RPE-P/TLIF for Lumbar Spinal Stenosis With Instability

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

Status
Completed
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Wen-xi Sun · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2018-09-04
Primary completion
2022-04-30
Completion
2024-02-01
First posted
2024-03-04
Last updated
2024-03-04

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06290908. Inclusion in this directory is not an endorsement.