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Clinical efficacy of an innovative surgical treatment for lumbar degenerative disease

Clinical efficacy of an innovative surgical treatment for lumbar degenerative disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037155
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

lumbar degenerative disease

Interventions

Improved TLIF group:Insertion after Fixation
Traditional TLIF group:Fixation after Insertion

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged = 80 years; 2. Non-pregnant and lactating women; 3. Patients are suffering from lumbar intervertebral disc protrusion in lumbar disc pathological basis, with outstanding intervertebral disc tissue and (or) stimulating nerve root, horsetail nerve compression caused by the clinical syndrome, characterized by low back pain, lower limb radiation pain, numbness, lower limb weakness, sphincter dysfunction, etc.), merger or lumbar spinal stenosis disease (refers to a variety of reasons cause all lines shorten the vertebral canal, oppression dural sac and spinal cord or nerve root, which may lead to a corresponding class of nerve dysfunction disease); 4. Lumbar imaging examination (plain film, CT and MRI) was performed to diagnose lumbar disc degeneration, compression of nerve tissue (spinal cord or nerve root) caused by a herniated disc, or compression of nerve tissue caused by stenosis at all diameter lines of spinal canal and outlet of nerve root. 5. Obvious neurological symptoms caused by lumbar disc herniation pressing on nerve tissue, including low back pain, numbness and pain in lower limbs, and walking disorder;Physical examination patient positive straight leg elevation test, abnormal knee, tendon reflexes and other abnormal signs. 6. It is limited to patients with single lesion, and the neurological symptoms and signs of the patients are consistent with imaging examinations. 7. Conservative treatment for more than 6 months showed no significant improvement in symptoms, which seriously affected the quality of life of the patients. 8. The patient had a strong desire to accept surgical decompression, and fully understood the differences and complications between the two surgical methods in the study, so he signed the informed consent and volunteered to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with severe primary diseases such as cardiovascular, liver, kidney, hematopoietic system, mental illness and malignant diseases such as tumor. 2. Combined with congenital deformity of the lumbar spine, previous history of infection, tumor and trauma, etc., significant abnormal changes occurred in the shape of the lumbar spine. 3. There are compression diseases in other parts of the spine except the lumbar spine, such as cervical disc degeneration disease, cervical hyperextension injury, ossification of the posterior longitudinal ligament of the cervical vertebra, ossification of the posterior longitudinal ligament of the thoracic vertebra, ossification of the thoracic ligamentum flavum, etc. 4. There are other related diseases such as piriformis syndrome, sciatic nerve injury, poliomyelitis, Guillain-Barre syndrome, which affect nerve function and thus interfere with postoperative efficacy.

Design outcomes

Primary

MeasureTime frame
Immediate postoperative symptoms;

Secondary

MeasureTime frame
Lumbar JOA score;VAS lower back pain score;Complications;

Countries

China

Contacts

Public ContactGuo Yongfei

Shanghai Changzheng Hospital

guospine@163.com+86 13901609558

Outcome results

None listed

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