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A multicenter, prospective, randomized controlled trial of three minimally invasive surgery for lumbar disc herniation

A multicenter, prospective, randomized controlled trial of three minimally invasive surgery for lumbar disc herniation

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079335
Enrollment
Unknown
Registered
2024-01-01
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar disc herniation

Interventions

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who meet the diagnostic criteria and surgical indications of the "Diagnosis and Treatment Guidelines for Lumbar Intervertebral Disc Herniation" published in the Chinese Journal of Orthopedics in 2020, and also meet the following conditions: 1. Age = 18 years old 2. Symptoms: Radiation radicular pain, muscle weakness and/or sensory abnormalities in the innervated area of the affected nerve roots, with or without low back pain. 3. Physical signs: motor and/or sensory disorders innervated by affected nerve roots, with or without decreased tendon reflexes; Positive nerve pull test, such as Lasegue sign test, contralateral Lasegue sign test, femoral nerve pull test, etc; With or without local lumbar tenderness and limited mobility. 4. Lumbar MRI confirms that the segment of lumbar disc herniation is consistent with symptoms and signs. 5. The medical history exceeds 6-12 weeks and systematic conservative treatment is ineffective; During conservative treatment, symptoms are getting worsen or recur, affecting work or life.

Exclusion criteria

Exclusion criteria: 1. Previous history of lumbar spine surgery at the same or adjacent level 2. Cauda equina syndrome 3. Pregnancy 4. Concomitant severe underlying diseases (ASA>2) 5. The protrusion of intervertebral disc fragments exceeds half the height of adjacent vertebral bodies towards the head or tail end 6. Two or more intervertebral disc herniation require surgery 7. Combined lumbar instability, spinal tumors, spinal fractures, ankylosing spondylitis 8. Mental illness or cognitive impairment, communication difficulties, inability to complete questionnaire survey 9. There are surgical contraindications, such as systemic or local active infections, coagulation disorders, etc 10. Refusal to sign informed consent form

Design outcomes

Primary

MeasureTime frame
Oswestry disability index;

Secondary

MeasureTime frame
Visual analogue scale leg pain;Visual analogue scale back pain;Quebec back pain disability scale;Short form 36 health survey questionnaire ;Likert scale (7 levels);Operative time;Intraoperative bleeding;Hospitalization days;Lumbar surgical segment stability;Changes in the area of lumbar paravertebral muscles;Degree of fat formation in lumbar paravertebral muscles;Total hospitalization expenses;Cost of surgery;Cost of consumable material;

Countries

China

Contacts

Public ContactFuxin Wei

The Seventh Affiliated Hospital of Sun Yat-sen University

weifuxin@mail.sysu.edu.cn+86 135 6017 0686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026