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Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompression surgery. For certain patients with severe lumbar stenosis, additional posterior decompression is required. However, whether additional posterior decompression is necessary for these patients is unknown. Radiographic predictors of failed indirect decompression via LLIF is unknown. In current randomized, controlled trial , the investigators compare the clinical outcomes of patients with severe lumbar stenosis who received LLIF plus posterior decompression and those without posterior decompression.
The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody fusion. Patients in the other group received transpsoas lateral lumbar interbody fusion plus posterior decompression. Patients will be followed for one year. Clinical outcomes of the two groups will be compared. And radiographic predictors of failed indirect decompression via LLIF will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral lumbar interbody fusion | Experimental | Patients in this group received lateral lumbar interbody fusion alone. Patients who suffered residual neurologic symptoms postoperatively will received conservative treatment for at least 3 months.Patients were considered to have unsuccessful indirect decompression if they had less than 20% improvement according to the Oswestry Disability Index (ODI) by 3 months postoperatively. |
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| Lateral lumbar interbody fusion plus posterior decompression | Experimental | Patients in this group received lateral lumbar interbody fusion plus posterior decompression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lateral lumbar interbody fusion | Procedure | LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | The ODI is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability | Preoperative, 3-month, 12-month,24-month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | The VAS is a self-report measure of the intensity of pain (score range 0 - 10 ). A higher score indicates greater pain intensity. | Preoperative, 3-month, 12-month,24-month after surgery |
| Zurich Claudication Questionnaire(ZCQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Axial central canal area | The area of the spinal central canal with the most stenosis at the level of the intervertebral disc on MRI. | Preoperative,postoperative,12-month,24-month after surgery |
| Midsagittal canal diameter |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangcai Li, MD | The Second Affiliated Hospital of Medical College Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Medical College Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Patients included in this study are with degenerative lumbar stenosis and Schizas's stenosis grades C. Patients who suffered from significant lumbar scoliosis, grade 2 spondylolisthesis, lumbar fracture and prior lumbar surgery are excluded from this study.
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The ZCQ is a disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis.The result is expressed as a percentage of the maximum possible score (22.22% - 100%). The score increases with worsening disability.The The ZCQ consists of three subscales: symptom severity scale, physical function scale and patient's satisfaction with treatment scale. |
| Preoperative, 3-month, 12-month,24-month after surgery |
The canal diameter at the midsagittal slice on MRI.
| Preoperative,postoperative,12-month,24-month after surgery |
| anterior and posterior disc height | The disc height at the anterior and posterior rim of the intervertebral disc on X-ray. | Preoperative,postoperative, 6-month,12-month,24-month after surgery |
| The height of the bilateral intervertebral foramen | The distance of minimum diameter between adjacent pedicles on CT. | Preoperative,postoperative, 6-month,12-month,24-month after surgery |
| Disc angle | The angles of the lines parallel to the upper and lower endplates in the intervertebral space. | Preoperative,postoperative, 6-month,12-month,24-month after surgery |