An interventional study of Lateral lumbar interbody fusion in Lumbar Spine Degeneration and Lumbar Spinal Stenosis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 72 is close to the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Lateral lumbar interbody fusion
Patients in this group received lateral lumbar interbody fusion plus posterior decompression.
Procedure: Lateral lumbar interbody fusion
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.
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
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
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.
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
Zurich Claudication Questionnaire(ZCQ)
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.
Time frame: Preoperative, 3-month, 12-month,24-month after surgery
Axial central canal area
The area of the spinal central canal with the most stenosis at the level of the intervertebral disc on MRI.
Time frame: Preoperative,postoperative,12-month,24-month after surgery
Midsagittal canal diameter
The canal diameter at the midsagittal slice on MRI.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative,postoperative, 6-month,12-month,24-month after surgery
Plan to share: No
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University