Skip to content

Effects of the ''fixation-fusion'' sequence of lumbar surgery on surgical outcomes for lumbar spinal stenosis: a prospective multicenter randomized controlled clinical trial

Effects of the ''fixation-fusion'' sequence of lumbar surgery on surgical outcomes for lumbar spinal stenosis: a prospective multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048507
Enrollment
Unknown
Registered
2021-07-09
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

Lumbar stenosis

Interventions

Experimental group:Fixed and then fused
The control group:Fused and then fixed

Sponsors

Shanghai Changzheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Non-pregnant and lactating women; 3. The patient is suffering from lumbar spinal stenosis (refers to the clinical syndrome caused by nerve root and cauda equina nerve compression due to factors such as lumbar disc herniation or articular facet joint hyperplasia and stimulation, manifested as low back pain, lower extremity radiating pain, lower extremity numbness, lower extremity weakness, intermittent claudication, and even bowel and bladder dysfunction); 4. Diagnosis of lumbar spinal stenosis on lumbar spine imaging examinations (plain film, CT and MRI), caused by the compression of nerve tissue (spinal cord or nerve root) caused by herniated intervertebral disc or hyperplasia of facet joints, or the stenosis of nerve root outlet compression of nerve tissue; 5. Patients with obvious clinical symptoms of lumbar spinal stenosis, including low back pain, numbness and pain in lower limbs, intermittent claudication; physical examination patients with limited lumbar extension, positive or negative straight leg raising test, abnormal knee and tendon reflexes and other abnormal signs ; 6. Conservative treatment for more than 6 months, no significant improvement in symptoms, which seriously affects the patient's quality of life; 7. The patient has a strong willingness to accept surgery, and fully understands the differences and complications of the two surgical procedures in the clinical study, and signs the informed consent to voluntarily join the clinical trial.

Exclusion criteria

Exclusion criteria: 1.Complicated with cardiovascular, liver, kidney and hematopoietic system and other serious primary diseases, psychiatric patients and malignant diseases such as tumors; 2.Combined with congenital lumbar deformity, past history of infection, tumor history, trauma history, etc., resulting in obvious abnormal changes in the shape of the lumbar spine; 3.Presence of compression diseases in other parts of the spine except the lumbar spine, such as cervical intervertebral disc degenerative disease, cervical hyperextension injury, ossification of the posterior longitudinal ligament of the cervical spine, ossification of the posterior longitudinal ligament of the thoracic spine, ossification of the thoracic ligamentum flavum, etc; 4.There are other related diseases, such as piriformis syndrome, sciatic nerve injury, poliomyelitis, and Guillain-Barre syndrome, which affect nerve function and thus interfere with postoperative outcomes.

Design outcomes

Primary

MeasureTime frame
postoperative neurological symptoms;

Secondary

MeasureTime frame
Lumbar Japanese Orthopaedic Association Scores;pain score;

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 7, 2026