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Efficacy and prognosis of transforaminal endoscopy in the treatment of lumbar disc herniation in human immunodeficiency virus infected patients: a non-randomized, controlled, 2-year follow-up clinical study

Efficacy and prognosis of transforaminal endoscopy in the treatment of lumbar disc herniation in human immunodeficiency virus infected patients: a non-randomized, controlled, 2-year follow-up clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037464
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-30
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

lumbar disc herniation

Interventions

experimental group:nucleus pulposus enucleation under intervertebral foramen endoscope
control group:intervertebral disc fusion

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with clinically diagnosed lumber disc herniation with imaging evidence, which meets McCulloch's diagnostic criteria of lumbar disc herniation proposed in 1980; 2. Over 50% secondary spinal stenosis rate as shown on lumbar magnetic resonance images; 3. Patients agree to undergo transforaminal endoscopy and will not participate in other clinical trials to avoid the factors that influence study bias; 4. Meeting Chinas diagnostic criteria for human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) and treatment principles (2001): patients have all of the following conditions can be diagnosed suffering from AIDS, 1) an epidemiological history; 2) confirmed HIV antibody-positive; 3) serum HIV/RNA-positive; 4) one of any clinical manifestation. Patients can also be diagnosed with AIDS if they exhibit confirmed HIV antibody-positive or serum HIV-RNA-positive in addition to CD4+ T lymphocytes < 200/uL.

Exclusion criteria

Exclusion criteria: (1) Patients with coronary atherosclerosis and/or other basic diseases; (2) Patients with stroke, malignant tumor, brain injury and/or other diseases that affect the follow-up effect; (3) Patients with surgical contraindications including severe diabetes mellitus, liver disease, and abnormal coagulation function; (4) Patients who do not agree to be treated with transforaminal endoscopic surgery; (5) Patients with neuropsychiatric disorders; (6) Patients with lumbar disc herniation and severe lumbar degenerative disease caused by other complex causes.

Design outcomes

Primary

MeasureTime frame
The change of symptom improvement rate evaluated by JOA score at 24 months after surgery;

Secondary

MeasureTime frame
The change of symptom improvement rate at 6 and 12 months after surgery;Pain improvement rate evaluated by VAS at 6, 12 and 24 months after surgery;Operation time, amount of blood loss, hospital days;Recurrence rate of lumbar disc herniation at 6, 12 and 24 months after surgery;Incidence of adverse reactions at 6, 12 and 24 months after surgery;

Countries

China

Contacts

Public ContactMing Lu

Shanghai Public Health Clinical Center

luming_60@hotmail.com+86 18930813527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026