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The stromal vascular fraction is utilized for the purpose of preventing the recurrence of lumbar disc herniation following endoscopic surgery

The stromal vascular fraction is utilized for the purpose of preventing the recurrence of lumbar disc herniation following endoscopic surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090312
Enrollment
Unknown
Registered
2024-09-27
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

protrusion of lumbar intervertebral disc

Interventions

Lumbar endoscopic treatment group (A Group):only endoscopic treatment
Lumbar endoscopic treatment + Annulus suture group (B Group):endoscopic treatment + Annulus suture
Lumbar endoscopic treatment + Injection of stromal vascular fraction + Annulus suture group:endoscopic treatment + Injection of stromal vascular fraction +Annulus suture

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age > 18 years and < 80 years; ? Non-pregnant and lactating women; ? The patient is suffering from protrusion of lumbar intervertebral disc (refers to the clinical syndrome caused by lumbar disc degeneration, partial or total rupture of the annulus fibrosus, nucleus pulposus protrusion stimulation or compression of nerve roots and cauda equina nerve, radiating pain of lower extremities, numbness of lower extremities, and even urinary and bowel dysfunction); ?The imaging examination of the lumbar spine (CT, MRI) diagnosed single-level lumbar protrusion, protruding disc compression of nerve tissue (nerve root or spinal cord); ?Have obvious clinical symptoms of protrusion of lumbar intervertebral disc, including low back pain, lower limb numbness pain; The physical examination patients showed positive signs of straight leg elevation test and strengthening test, positive femoral nerve pulling test, and positive spinal spinous process tenderness and tapping pain. ?More than 2 weeks of conservative treatment, no significant improvement in symptoms, seriously affecting the quality of life of patients; ?The patient had a strong desire to undergo surgery, and fully understood the differences in biological products used in the clinical study and the complications of lumbar endoscopy surgery and fibrous suture, and signed informed consent to voluntarily join the clinical trial.

Exclusion criteria

Exclusion criteria: ? Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental patients and malignant diseases such as tumors; ? Combined with congenital lumbar deformity, previous infection history, tumor history, trauma history, etc., resulting in significant abnormal changes in lumbar morphology; ?Patients with lumbar instability or lumbar spondylolisthesis, lumbar fracture, tuberculosis or tumor; ? Patients who have previously undergone spinal surgery; ?Compression diseases in other parts of the spine other than the lumbar spine, such as cervical disc degeneration, cervical hyperextension, cervical posterior longitudinal ligament ossification, thoracic posterior longitudinal ligament ossification, thoracic ligamentum yellow ossification, etc.; ?There are other diseases such as piriformis syndrome, sciatic nerve injury, poliomyelitis, Guillain-Barre syndrome that affect nerve function and thus interfere with postoperative efficacy.

Design outcomes

Primary

MeasureTime frame
Postoperative recurrence rate;

Secondary

MeasureTime frame
VAS score;ODI;

Countries

China

Contacts

Public ContactChengzhen Liang

Department of Orthopedic Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine

liangchengzhen@zju.edu.cn+86 150 6817 4387

Outcome results

None listed

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