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NCT Number: NCT06290908

RPE-P/TLIF 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.

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Key information

Conditions

Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RPE-P/TLIF

Procedure

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

Primary outcomes

  1. Pain visual analog scale (VAS)

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

    Pain assessment, assessing lower back pain and lower limb pain.

Secondary outcomes

  1. Oswestry disability index (ODI)

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

    Evaluate neurological function

  2. MacNab criteria

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

    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.

  3. intervertebral space height

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

    Imaging evaluation indicators:

  4. lumbar physiological curvature

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

    Imaging evaluation indicators:

  5. fusion rate

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

    Imaging evaluation indicators:

  6. pedicle screw accuracy

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

    Imaging evaluation indicators:

Sponsors and collaborators

Lead sponsor

Wen-xi Sun

Other

Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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